FRAMEWORK CONTRACT TENDER No ECHA ... - ECHA - Europa

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FRAMEWORK CONTRACT TENDER No ECHA ... - ECHA - Europa

16/06/2008 15:15

FRAMEWORK CONTRACT

TENDER No ECHA/2008/24

TITLE: Development of a Chemical Safety Assessment tool

SPECIFICATIONS

1. Introduction to the European Chemicals Agency ................................................................... 8

2. General information concerning the invitation to tender....................................................... 9

2.1 Nature of the contract........................................................................................................... 9

2.2 Duration................................................................................................................................ 9

2.3 Period of validity of the tender........................................................................................... 10

2.4 Participation in the tendering procedure ............................................................................ 10

2.5 Joint offers and subcontracting .......................................................................................... 11

2.5.1 Joint Offers................................................................................................................. 11

2.5.2 Subcontracting............................................................................................................ 13

2.6 Budget ................................................................................................................................ 14

2.7 Terms of payment............................................................................................................... 14

2.8 Guarantees.......................................................................................................................... 14

2.9 General terms and conditions for the submission of tenders ............................................. 14

2.10 Contact between the tenderer and the Agency................................................................... 14

2.11 No obligation to award the contract ................................................................................... 14

2.12 Place of performance.......................................................................................................... 14

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3. Form and Content of the tender ............................................................................................. 14

3.1 General ............................................................................................................................... 14

3.2 How to submit a tender ...................................................................................................... 14

3.3 Structure of the tender........................................................................................................ 14

3.3.1 Section One: Administrative proposal ....................................................................... 14

3.3.2 Section Two: Technical proposal............................................................................... 14

3.3.3 Section Three: Financial proposal.............................................................................. 14

4. Assessment and award of the contract ................................................................................... 14

4.1 Stage 1 - application of exclusion criteria and exclusion of tenderers............................... 14

4.2 Stage 2 - application of selection criteria (selection of tenderers) ..................................... 14

4.2.1 Selection criteria......................................................................................................... 14

4.2.2 Evidence of economic and financial capacity of the service provider....................... 14

4.2.3 Evidence of the technical and professional capacity of the service provider(s) ........ 14

4.3 Stage 3 - Award criteria for the Choice of the Contractor ................................................. 14

4.3.1 Technical Merit .......................................................................................................... 14

4.3.2 Price (P)...................................................................................................................... 14

4.4 Award of the contract and information to tenderers .......................................................... 14

4.4.1 Opening of tenders ..................................................................................................... 14

4.4.2 Information to tenderers............................................................................................. 14

4.4.3 Conclusion of the contract.......................................................................................... 14

4.5 Data protection ................................................................................................................... 14

5. Technical specifications ........................................................................................................... 14

5.1 Background ........................................................................................................................ 14

5.1.1 General context .......................................................................................................... 14

5.1.2 The Chemical Safety Assessment tool- generalities and context............................... 14

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5.1.3 Analysis and design project: Study on IT tool to assist the development of Chemical

Safety Reports ............................................................................................................................ 14

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5.1.3.1 Deliverables of the analysis and design project ..................................................... 14

5.1.3.2 Description of the functionalities of version v.1.0 foreseen in the project ............ 14

5.1.3.2.1 Introduction ...................................................................................................... 14

5.1.3.2.2 Elements of the CSA tool................................................................................. 14

5.2 Objective of the contract .................................................................................................... 14

5.3 Project timing ..................................................................................................................... 14

5.4 Project planning.................................................................................................................. 14

5.5 Project organisation............................................................................................................ 14

5.5.1 Stakeholder consultation ............................................................................................ 14

5.5.2 Meetings, minutes and deliverables ........................................................................... 14

5.6 Profiles ............................................................................................................................... 14

5.6.1 Project Manager ......................................................................................................... 14

5.6.2 Project Assistant......................................................................................................... 14

5.6.3 Senior scientist ........................................................................................................... 14

5.6.4 Junior scientist............................................................................................................ 14

5.6.5 Quality consultant ...................................................................................................... 14

5.6.6 User requirements analyst .......................................................................................... 14

5.6.7 Senior Analyst-Programmer....................................................................................... 14

5.6.8 Programmer................................................................................................................ 14

5.6.9 Junior programmer ..................................................................................................... 14

5.6.10 Technical writer.......................................................................................................... 14

5.6.11 Web designer-developer............................................................................................. 14

5.6.12 Web developer............................................................................................................ 14

5.7 Coverage of the contract .................................................................................................... 14

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5.7.1 Analysis of requirements............................................................................................ 14

5.7.2 System Analysis & Design, Implementation, Testing, Deployment and Maintenance

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5.7.3 Communication and training activities ...................................................................... 14

5.8 Description of case studies................................................................................................. 14

5.8.1 Case study 1: Exposure scenario generation.............................................................. 14

5.8.2 Case study 2: First version of a CSA tool .................................................................. 14

6. Terminology and acronyms..................................................................................................... 14

7. Annexes ..................................................................................................................................... 14

Annex 1: Model of declaration of honour with respect to the Exclusion Criteria and absence of

conflict of interest............................................................................................................................. 14

Annex 2: Templates for summary of CV and project descriptions............................................. 14

Annex 3: Powers of attorney ........................................................................................................... 14

Annex 4: Letter of Intent Subcontractor ....................................................................................... 14

Annex 5: Draft framework service contract.................................................................................. 14

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1. INTRODUCTION TO THE EUROPEAN CHEMICALS AGENCY

REACH Regulation (EC) No 1907/2006 1 concerning the Registration, Evaluation, Authorisation

and Restriction of Chemicals has been adopted on the 18 December 2006 and entered into force on

the 1st June 2007. It established the European Chemicals Agency (hereinafter referred to as “the

Agency”) in Helsinki, Finland.

The Agency is operational as of 1 June 2008. It will manage the registration, evaluation,

authorisation and restriction processes for chemical substances to ensure consistency across the

European Union. These REACH processes are designed to provide additional information on

chemicals, to ensure their safe use, and to ensure competitiveness of the European industry.

More information can be found on http://echa.europa.eu/home_en.html

2. GENERAL INFORMATION CONCERNING THE INVITATION TO TENDER

These specifications follow the publication of:

• the Prior Information Notice 2008/S 62-083189, published in the Official Journal S62 of 29

March 2008

• the contract notice 2008/S 115-152918, published in the Official Journal S115 of 14 June

2008.

2.1 Nature of the contract

Framework service contract for the scientific development and IT implementation of a chemical

safety assessment tool to be used under the REACH Regulation.

2.2 Duration

The indicative intended commencement date of the framework contract is October 2008. The initial

duration of the framework contract shall be 24 months.

The execution of the tasks may not start before the contract has been signed. The period of

execution of the tasks may be extended (each time for a period of 12 months), only with the written

agreement of the contracting parties, before the end of the period originally stated in the contract.

1 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European

Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and

Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives

91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006); amended by Council Regulation (EC) No

1354/2007 of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the

Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), by reason of the

accession of Bulgaria and Romania (OJ L 304, 22.11.2007, p. 1).

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The framework contract may be renewed twice, each time for a period of 12 months (total possible

contract duration 48 months) under the same conditions as the original framework contract.

However, the Agency reserves the right not to renew the framework contract. Renewal does not

imply any modification or deferment of existing obligations.

2.3 Period of validity of the tender

The offer must remain valid for a period of 9 months following the final date for submitting tenders

(see below). During this period, tenderers must keep their bids open in respect of all the conditions

therein.

2.4 Participation in the tendering procedure

The competition is open to any physical person or legal entity coming from countries within the EU

and any other physical person or legal entity from a third country that has concluded with the

Communities a specific agreement in the area of public contracts, under the conditions provided for

in that agreement.

Where the Multilateral Agreement on Public Contracts concluded within the framework of the WTO

applies, the contracts are also open to nationals (natural or physical) of States that have ratified this

Agreement under the conditions provided for therein. It should be noted that research and

development services, which come under category 8 of Annex II-A of Directive 2004/18/EC, are not

covered by this Agreement.

In practice, the participation of applicants from third countries that have concluded a bilateral or

multilateral agreement with the Communities in the area of public contracts must be allowed, under

the conditions provided for in that agreement.

2.5 Joint offers and subcontracting

Both joint offers and subcontracting are allowed in response to this call for tenders. Offers may even

combine both approaches.

In any case, the tender documents must specify very clearly whether each company involved in the

tender is acting as a partner in a joint offer or as a subcontractor (this also applies where the various

companies involved belong to the same group, or even where one is the parent company of the

others).

The implications of these two models of collaboration are radically different and the details are

outlined below:

2.5.1 Joint Offers

Partners in a joint offer assume joint and several liability towards the Agency for the performance of

the contract as a whole.

Statements saying, for instance:

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• that one of the partners of the joint offer will be responsible for part of the contract and

another one for the rest, or

• that more than one contract should be signed if the joint offer is successful

are thus incompatible with the principle of joint and several liability. The Agency will disregard any

such statement contained in a joint offer, and reserves the right to reject such offers without further

evaluation on the grounds that they do no comply with the tendering specifications.

In case of a tenderer submitting a joint offer who has already set up a consortium or similar entity

for conducting the project in case a contract will be awarded, the tenderer should mention this fact in

the tender, together with any other relevant information in this connection.

In case of tenderers submitting a joint offer who have not yet set up a consortium or similar entity,

the tenderers should be aware that, in case the tenderers are awarded the contract, the Agency will

require the tenderer to give a formal status to this collaboration before the contract is signed. This

can take the form of:

• an entity with legal personality recognised by a Member State; or

• an entity without legal personality but offering sufficient protection of the Agency’s

contractual interests (depending on the Member State concerned, this may be, for

example, a consortium or a temporary association).

In case of tenderers submitting a joint offer the tenderers are asked to fill in and duly sign one of the

attached powers of attorney (Annex 3), depending on the set-up that has been chosen by the

tenderers.

2.5.2 Subcontracting

Certain tasks provided for in the contract may be entrusted to subcontractors, but the main

contractor retains full liability towards the Agency for performance of the contract as a whole.

Accordingly:

• the Agency will treat all contractual matters (e.g. payment) exclusively with the main

contractor, whether or not the tasks are performed by a subcontractor;

• under no circumstances can the main contractor avoid liability towards the Agency on

the grounds that the subcontractor is at fault.

If the tenderer envisages subcontracting, the tender must include:

• a document clearly stating the roles, activities and responsibilities of the proposed

subcontractor(s), and the reasons why subcontracting is envisaged;

• a letter of intent (see Annex 4) by each proposed subcontractor stating his/her intention

to collaborate with the tender if the tenderer wins the contract and his/her willingness

to accept the tasks and the terms and conditions set out in 2.9 in particular Article II.17

of the draft service contract (Annex 5).

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Where the total amount envisaged for subcontracting is above 30% of the total contract value,

evidence of the potential subcontractor(s) ability to perform the tasks entrusted to him/them shall be

included in the offer. Such evidence is the same as that also required from the contractor, as

described and identified below (in Section 3.2).

Where the total amount envisaged for subcontracting is above 50% of the total contract value, the

potential subcontractor(s) must also present evidence of compliance with the exclusion criteria (as

required from the potential contractor) described below. (Section 4.1).

Tenderers should note that the Agency will consider intended subcontracting below 30% of the

contract value as an indication that the potential contractor has the resources to complete the tasks

under the contract, as well as a factor potentially enhancing the proposed team organisation.

During execution of the contract, the contractor will need the Agency’s express authorisation to

replace one subcontractor with another and/or to subcontract tasks for which subcontracting was not

envisaged in the original offer.

2.6 Budget

For guidance purposes, the maximum budget allocation to this contract is fixed at EUR 2,000,000

over its initial duration of two years. Subsequent renewals, as specified above, will be of two 12month

periods and would have an additional maximum budget allocation of EUR 500,000 for each

12 month period. Thus, if renewals were made to extend the contract to four years, the maximum

budget allocation during that period would be EUR 3,000,000, although the actual allocation may be

lower depending on the needs that arise.

2.7 Terms of payment

Payments shall be made in accordance with Article II.4 of the draft framework contract (Annex 5)

and Article 4 of the draft specific contract (Annex V to the draft framework contract in Annex 5).

Specific contracts will be drawn up following either the fixed price or the quoted times and means

method as set out in Annex III of the draft framework contract in Annex 5.

2.8 Guarantees

Performance Guarantee

The Agency may require that a performance guarantee for an amount of EUR 100.000,00 (one

hundred thousand) shall be issued by a bank, an authorised financial institution or a third party in

favour of the Agency. It shall be released six (6) months after complete execution and payment of

the balance of the last Specific Contract. It shall cover performance of the Contract in accordance

with the terms set out in the Contract, and notably with the terms set out in the Annexes.

The Agency reserves the right to request an additional performance guarantee with respect to the

Specific Contracts which proportionally represent a relevant value in relation to the Framework

Contract.

Prefinancing Guarantee

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The Agency may only require a pre-financing guarantee for the cases where a pre-financing is

foreseen for a specific contract and where this is deemed to be prudent financial management for the

Agency. Such a case will occur where the financial situation of the contractor is considered not to be

solid by the Agency.

The Agency will always require a pre-financing guarantee in case the amount of the pre-financing is

above EUR 150,000.

2.9 General terms and conditions for the submission of tenders

• Submission of a tender implies that the Contractor accepts all the terms and conditions

set out in these specifications (including the annexes) and waives all other terms of business.

• Submission of a tender binds the Contractor to whom the contract is awarded during

performance of the contract.

• Once the Agency has accepted the tender, it shall become the property of the Agency

and the Agency shall treat it confidentially.

• The Agency shall not reimburse expenses incurred in preparing and submitting tenders.

• The Protocol on the Privileges and Immunities or, where appropriate, the Vienna

Convention of 24 April 1963 on Consular Relations shall apply to this invitation to tender.

• Variants are not allowed.

2.10 Contact between the tenderer and the Agency

In principle, no contact is permitted between the Agency and the tenderers during the contract award

procedure.

However, in exceptional circumstances contact may be made on the tenderers' initiative before the

final date for the receipt of bids, in order (and only for this reason) to clarify the nature of the

contract. The Agency is not bound to reply to requests for additional information made less than five

working days before the deadline for submission of tenders.

Such requests for further information may be made in writing only to the following e-mail address:

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reach-impl@echa.europa.eu

Please mention as subject « ECHA/2008/24 »

Insofar as it has been requested within the time limit specified above, the questions raised and the

additional information provided by the Agency will be published on the website at:

http://echa.europa.eu/opportunities/procurement_en.asp

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All tenderers are advised to take note of the fact that no additional information will be sent (neither

by post nor by e-mail) regarding new information that has become available. Therefore, all tenderers

are kindly requested to visit the above-mentioned website frequently prior to submitting bids.

Similarly, contact may in exceptional circumstances be made on the Agency's initiative:

• before the final date for the receipt of bids, in order to inform interested parties of an

error, a lack of precision, an omission or any other material shortcoming in the drawing up

of the documents of the invitation to tender;

• or, after the opening of bids, where a bid requires clarification or in order to correct

material errors made in drawing up a bid.

Please note that in any event such contact may not result in a modification of the terms of the bid. In

case the Agency deems it appropriate to provide additional information it will be published on the

website mentioned above.

2.11 No obligation to award the contract

The tendering procedure shall not involve the Agency in any obligation to award the framework

contract nor to issue any specific contract under this framework contract. No compensation may be

claimed by tenderers whose tender has not been accepted, including when the Agency decides not to

award the contract.

2.12 Place of performance

The place of performance of the tasks shall normally be the contractor’s premises or any other place

indicated in the tender. In exceptional circumstances, if specified in the specific contract, the

services can be carried out in the Agency’s premises or other premises, as agreed between the

contractor and the Agency. Such circumstances may arise, for instance, if training, workshops or

software installation services are required.

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3. FORM AND CONTENT OF THE TENDER

3.1 General

Tenders must be clear and concise, with continuous page numbering, and assembled in a coherent

fashion (e.g. bound or stapled, etc.). Since tenderers will be judged on the content of their written

bids, these must make it clear that they are able to meet the requirements of the specifications.

A tender must be written in one of the official languages of the European Union.

3.2 How to submit a tender

Submission of a tender implies that the tenderer accepts all the terms and conditions set out in the

specifications.

Tenders may be:

a) either sent by registered mail, posted no later than 01/08/2008, (date of postmark); to

the following address:

European Chemicals Agency (ECHA)

Invitation to tender No: ECHA/2008/24

Financial Unit R1

PO Box 400

00121 Helsinki

Finland

b) or sent by courier services, no later than 01/08/2008 (date of deposit slip), to the

following address:

European Chemicals Agency (ECHA)

Invitation to tender No: ECHA/2008/24

Financial Unit R1

Annankatu 18

00120 Helsinki

Finland

c) or delivered by hand, in person or by an authorised representative no later than 16:00

hours on 01/08/2008, (date of acknowledgement of receipt by the Agency) to the address

mentioned above.

The tender must be submitted under double sealed cover. The outer envelope should bear the

address as mentioned above. The inner envelope should be addressed to the Financial Unit R1 and

marked "Invitation to tender No ECHA/2008/24" and "Not to be opened by the internal mail

service". If self-adhesive envelopes are used, they must be sealed with adhesive tape and the sender

must sign across the tape. The inner envelope must also contain three sealed envelopes, one

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containing the administrative proposal, the second the technical proposal and the third the financial

bid. Each of these envelopes must clearly indicate the content .The administrative proposal, the

technical proposal and the financial bid must be submitted, in duplicate (one set of originals and one

set of copies) and a third set in electronic format (on CD ROM).

Tenderers shall observe precisely the above indications in order that tenders reach their specified

destination in due time.

Evidence of timely submission by post or courier service will be constituted by the date of the

postmark or the date of the deposit slip. In the case of hand-delivery, the signed and dated

receipt will serve as evidence.

Reminder: Late delivery will lead to the exclusion of the tender from the award procedure for

this contract. Offers sent by e-mail or by fax will also be non admissible. Envelopes found

open at the opening session will also lead to non admissibility of the tender. Consequently,

tenderers must ensure that their bids are packed in such a way as to prevent any accidental

opening during its mailing.

3.3 Structure of the tender

All bids must be presented in three sections:

3.3.1 Section One: Administrative proposal

To identify himself the tenderer must fill in a Legal Entity Form and a Financial Identification

Form:

The Legal Entity Form is to be signed by a representative of the tenderer authorised to sign

contracts with third parties. This form is available at:

http://europa.eu/comm/budget/execution/legal_entities_en.htm

The Financial identification form shall be duly filled in and signed by an authorised representative

of the tenderer and his or her banker. The form is available at:

http://europa.eu/comm/budget/execution/ftiers_en.htm.

The above forms must be accompanied by the evidence as indicated at the bottom of each form.

Furthermore, the administrative proposal contains:

• the Declaration of honour with respect to the Exclusion criteria and absence of conflict

of interest, and,

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• documentary proof related to the selection criteria

3.3.2 Section Two: Technical proposal

This section is of great importance in the assessment of the bids, the award of the contract and the

future execution of any resulting contract. Some guidelines are given below, but attention is also

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drawn to the award criteria, which define those parts of the technical proposal to which the tenderers

should pay particular attention. The technical proposal should address all matters laid down in the

technical specifications as described in section 5 and should include models, examples and technical

solutions to problems raised in these specifications giving an answer to each of the points mentioned

with regard to the methodology, deadlines and organisation. The level of practical details provided

in the tender will be extremely important for the evaluation of the tender.

The technical specifications and the tenderer’s bid shall be integral parts of the contract and will

constitute annexes to the contract.

3.3.3 Section Three: Financial proposal

The tenderer's attention is drawn to the following points:

Pr = Po x (Ir/Io)

Pr - revised price.

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• prices must be expressed in euros;

• prices should be quoted free of all duties, taxes and other charges, i.e. also free of

VAT, as the Communities are exempt from such charges in the EU under Articles 3

and 4 of the Protocol on the Privileges and Immunities of the European Communities

of 8 April 1965 (OJEC L 152 of 13 July 1967). Exemption is granted to the Agency by

the governments of the Member States, either through refunds upon presentation of

documentary evidence or by direct exemption. For those countries where national

legislation provides an exemption by means of a reimbursement, the amount of VAT is

to be shown separately. In case of doubts about the applicable VAT system, it is the

tenderer's responsibility to contact his national authorities to clarify the way in which

the European Community is exempt from VAT;

• prices shall be fixed and not subject to revision for the first period of 24 months laid

down in the framework contract. In case of renewal in accordance with Article I.2.5. of

the framework contract (Annex 5) for one or two additional periods of 12 months, the

applicable price tables of the framework contract may be revised upwards or

downwards. This revision will be made only if one of the contracting parties requests it

by registered mail received by the other party not later than three months before the

second anniversary of the date on which the contract was signed. This revision shall be

determined by the trend in the harmonised consumer price index MUICP (Monetary

Union Index of Consumer Prices) published for the first time by the Office for Official

Publications of the European Communities on the Eurostat website

http://epp.eurostat.ec.europa.eu (Economy and Finance; Prices; HICP – Harmonized

Indices of Consumer Prices - Monthly data (index)). Revision shall be calculated in

accordance with the following formula:

Po - price in the original tender.

Io - monthly index of the final date for submitting tenders.

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Ir - monthly index of the date on which the request for price revision was received.

The reference price for the award of the framework contract shall be based on unit prices reported in

Table 1 (daily rate for the profiles as outlined in Section 5.6). A repartition of number of days for a

task which would necessitate 110 days of work is provided in the “number of days” column. This

repartition is artificial and does not represent a final view of what is felt necessary by the Agency for

the whole project. A weighted price shall be calculated as the daily rates multiplied by the number

of days for each profile in Table 2. The sum of those individual prices will be used for the award

criteria for price.

Upon signature of the framework contract, the reference price table shall be included in Annex I of

the framework contract as a reference price list.

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Table 1: Reference prices for profiles which may be required under this framework contract:

Profile Daily rate in EUR

Project Manager

Project assistant

Scientists profiles

Senior scientist

Junior scientist

IT profiles

Quality Consultant

User Requirements Analyst

Senior Analyst Programmer

Programmer

Junior programmer

Technical writer

Web designer-developer

Web developer

The profiles portrayed in Table 1 and 2 are described in section 5.6

Table 2: Price evaluation

Profile Number of days Price= daily rate (see Table 1)* number of days

Project Manager 5

Project assistant 5

Scientists profiles

Senior scientist 10

Junior scientist 10

IT profiles

Quality Consultant 5

User Requirements Analyst 3

Senior Analyst Programmer 15

Programmer 15

Junior programmer 10

Technical writer 2

Web designer-developer 15

Web developer 15

Total price sum

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4. ASSESSMENT AND AWARD OF THE CONTRACT

The assessment will be based on the bid of each tenderer.

The procedure for the award of the contract will be carried out in three successive stages. Only bids

meeting the requirements of one stage will be examined in the following stage.

The aim of each of these stages is:

Stage 1: to check, in the first stage (Exclusion criteria), whether tenderers can take part in the

tendering procedure and, where applicable, be awarded the contract;

Stage 2: to check, in the second stage (Selection criteria), the technical and professional capacity as

well as the economic and financial capacity of each tenderer who has passed the exclusion stage;

Stage 3: to assess on the basis of the award criteria each bid which has passed the exclusion and

selection stages.

In the case of joint tenders, the exclusion, selection and award criteria will be applicable to all the

members of the consortium. The same principle will also be applied in the case where there are subcontractors

depending on their participation in the project (see section 2.5). The bid must clearly

identify the subcontractors and document their willingness to accept the tasks and thus acceptance of

terms and conditions. Tenderers must inform the subcontractors that Article II.13 of the standard

contract will be applied to them. Once the contract has been signed, Article II.17 of the above

mentioned contract shall govern subcontractors.

4.1 Stage 1 - application of exclusion criteria and exclusion of tenderers

Tenderers falling within one or more of the following categories will automatically be excluded

from the tendering procedure:

(a) they are bankrupt or being wound up, are having their affairs administered by the courts, have

entered into an arrangement with creditors, have suspended business activities, are the subject of

proceedings concerning those matters, or are in any analogous situation arising from a similar

procedure provided for in national legislation or regulations;

(b) they have been convicted of an offence concerning their professional conduct by a judgment

which has the force of res judicata;

(c) they have been guilty of grave professional misconduct proven by any means which the

contracting authority can justify;

(d) they have not fulfilled obligations relating to the payment of social security contributions or the

payment of taxes in accordance with the legal provisions of the country in which they are

established or with those of the country of the contracting authority or those of the country

where the contract is to be performed;

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(e) they have been the subject of a judgment which has the force of res judicata for fraud,

corruption, involvement in a criminal organisation or any other illegal activity detrimental to the

Communities' financial interests;

(f) they are currently subject to an administrative penalty for being guilty of misrepresentation in

supplying the information required by the contracting authority as a condition of participation in

the procurement procedure or failing to supply an information, or being declared to be in serious

breach of his obligation under contract covered by the budget.

Tenderers or their representatives must fill in and sign the form in Annex 1 of this document. By

completing this form, tenderers state whether or not they are in one or more of the situations

described in the form. The tenderer to whom the contract is to be awarded agrees to submit to the

Agency those certificates or documents demonstrating that the tenderer is not in any of the situations

described under points (a), (b), (d) and (e) above within 15 calendar days from the date on which the

award is notified.

4.2 Stage 2 - application of selection criteria (selection of tenderers)

This part of the assessment concerns the criteria and evidence relating to the technical and

professional capacity and economic and financial capacity of the service provider(s) involved in the

bid. It should also contain any other document that the tenderer(s) wish(es) to include by way of

clarification.

An economic operator may rely on the capacities of other entities, regardless of the legal nature

of the links which it has with them. In that case, evidence must be provided that it will have at its

disposal the resources necessary for performance of the contract, for example by producing a clear

undertaking on the part of those entities to place those resources at its disposal.

If several service providers are involved in the bid, each of them must have the professional and

technical capacity, the necessary economic and financial capacity to perform the tasks assigned to

them in the tender.

This rule applies to all legal entities once they have chosen to be tenderers. If the tender includes

subcontractors, the Agency reserves the right to request evidence of their economic and financial

capacity if the tasks subcontracted represent a substantial part of the contract.

4.2.1 Selection criteria

Only those tenders fulfilling all the selection criteria will be examined in the light of the award

criteria. The selection criteria are set out below.

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SELECTION CRITERIA

1. FINANCIAL AND ECONOMIC CAPACITY

An average annual turnover of 1.5 million EUROS over the past 3 years. A consolidated

17


assessment shall be made for joint offers (all members of the consortium together) and in case

of subcontracting (tenderer plus subcontractor) to the extent that the subcontractor puts its

resources at the disposal of the tenderer for the performance of the contract.

2. TECHNICAL AND PROFESSIONAL CAPACITY

2.1 The tenderer must have managed successfully a minimum of 2 projects similar in subject

and size to the services to be performed under the framework contract.

2.2 Demonstrated ability and means available to carry out the work plan: reliability in terms of

sufficient resources to perform all the tasks within the period foreseen by the contract. The

tenderer has to have in active employment at least the following key personnel :

16/06/2008 15:15

- Two people corresponding to the profile of senior scientist and junior scientist with

experience in the fields of chemicals risk assessment including the use of existing chemical

assessment tools. In addition, experience in implementation of risk assessment

methodologies into supporting IT tools should be demonstrated. Solid experience linked to

the development of the exposure scenarios and chemical safety assessment according to the

REACH Regulation is requested. The active participation of each scientist in a minimum of

two relevant projects (linked to exposure scenario development, and chemical safety

assessment or exposure modelling) is requested. At least one project should be related to IT

aspects for one of them. One person should be identified as coordinator for the scientific

content aspects of the project.

- A Project Manager with overall responsibility for the execution and completion of the

contract. The Project Manager must have documented knowledge (minimum Master’s

degree) and at least 8 years experience of managing successfully IT projects of comparable

size. He should document his capacities in understanding the subject of this project. The

project manager should have managed a minimum of 3 different projects of a similar size.

The description of his involvement in and contributions to projects relevant for this project

(concretely illustrated) has to be provided.

- At least one person for each one of the IT profiles described in section 5.6.

2.3 Demonstrated high quality in technical writing in English

4.2.2 Evidence of economic and financial capacity of the service provider

All tenderers and subcontractors whose tasks are likely to represent 30% or more of the total volume

of the framework contract must provide proof of economic and financial capacity by presenting the

following documents:

a) a complete copy of the tenderer's audited annual accounts (balance sheet, profit and loss

account, notes on the accounts and auditors' remarks) of the past three years, as approved by the

general assembly of the company and, where applicable, published;

b) a statement of overall turnover and turnover concerning the tasks, supplies or services covered

by this contract for the last three financial years;

18


c) appropriate statements from banks or evidence of professional risk indemnity.

If, for some exceptional reason which the Agency considers justified, a tenderer is unable to provide

one or other of the above documents, he may prove his economic and financial capacity by any

other document which the Agency considers appropriate. In any case, the Agency must at least be

notified of the exceptional reason and its justification in the tender. The Agency reserves the right to

request any other document enabling it to verify the tenderer's economic and financial capacity.

4.2.3 Evidence of the technical and professional capacity of the service provider(s)

Evidence for selection criterion 2.1

A detailed description of all the projects (minimum two) should be provided according to the

template in Annex 2.

Evidence for selection criterion 2.2

A statement of the manpower and the number of managerial staff which is available for the services

required.

The core personnel responsible for carrying out the service are required to provide details of their

educational and professional qualifications, and their relevant work experience in the form of a

Europass Curriculum Vitae (CV) (format available on

http://europass.cedefop.europa.eu/europass/home/vernav/Europasss+Documents/Europass+CV/navi

gate.action?locale_id=1). In addition a summary of all profiles should be provided according to the

table provided in Annex 2.

For the scientists and the project manager the description of their involvement in and contributions

to projects relevant for this project (concretely illustrated) has to be provided.

A detailed description of those projects should be according to the template provided in Annex 2.

The Agency shall be authorised to contact the indicated contact person of the recipient to verify the

reference. Where the services were provided to contracting authorities, evidence of performance

shall be in the form of certificates issued or countersigned by the competent authority.

Evidence for selection criterion 2.3

List of previous projects and deliverables performed in English as well as an excerpt of a technical

draft relating to a previous project concerning similar deliverables in English.

By submitting a tender, each legal entity involved therein accepts the possibility of a check being

carried out by the Agency on its technical capacities and, if necessary, on its quality control

measures.

In addition, all tenderers are informed that they may be asked to prove that they are authorised to

perform the contract under national law, as evidenced by inclusion in a professional or trade

register or a sworn declaration or certificate, membership of a specific organisation, express

authorisation, or entry in the VAT register.

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Tenderers' attention is drawn to the fact that any total or partial omission

of information for which one or more service providers involved in the

tender are responsible may lead the Agency to exclude the tender from the

rest of the procedure.

4.3 Stage 3 - Award criteria for the Choice of the Contractor

The contract will be awarded to the most economically advantageous tender on the basis of the

following criteria:

• Technical Merit (TM) (70 points)

• Price (P) (30 points)

The Contract will be awarded to the tenderer who has obtained the highest total value of X,

composed as follows:

4.3.1 Technical Merit

X = TM + P

The quality of the approach is evaluated as follows: a maximum of 70 quality points will be given to

the tender which best satisfies the following sub-criteria:

N Sub-criteria Weighing

(maximum

Points)

1 Completeness and coverage of the overall proposal. Logical structure,

readability of the overall proposal.

2 Project management and coordination: (e.g. coordination instruments

between the different aspects of the project; communication

mechanisms envisaged with the Agency; repartition of tasks between

the different teams; coverage of expertise and technical capacities of

each team; measures to ensure the availability of the key personnel).

3 Creativity, scientific and technical relevance of the proposal (e.g.

understanding of the request, scientific and technical appropriateness

of the proposed solution, justification of the proposed solution (e.g.

against alternative potential solutions))

4 Project organisation (e.g. feasibility of proposed solution in term of

timing, appropriateness of personnel suggested for the tasks,

creativity of project management mechanisms for optimisation of

work)

15

15

20

20

20


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Total number of quality points 70

Tenders should elaborate on all points addressed by these specifications in order to score as many

points as possible. The mere repetition of mandatory requirements set out in these specifications,

without going into detail or without giving any added value, will only result in a very low score. In

addition, if certain essential points of these specifications are not expressly covered by the tender,

the Agency may decide to give a zero mark for the relevant award criteria.

The selected tenders are assessed according to the above qualitative award criteria.

Award criterion 1: the completeness of the offer will be assessed on the basis of the description of

the coverage of the contract described in section 5.7.

Award criterion 2: the assessment of the coordination mechanisms and general project organisation

will be assessed based on the relevant part of the offer.

Award criteria 3 and 4: will be assessed based on the response provided by the tenderer for the case

studies outlined in section 5.8.1. and5.8.2.

The CSA project is, at this point in time, in the process of completing the elaboration phase. As

described in section 5.1.3 an ”analysis and design” project has been finalised but further design steps

will be needed before starting the actual build of the tool. Since it is not yet possible to publish a

complete design in the context of this call for tender a case study approach has been chosen with the

objective to let the tenderer illustrate their ideas on how to approach these case studies. Hence in the

tender documents a tenderer is not asked to deliver the draft study (or deliverables) itself.

The tenderers should, for each case study, describe in detail:

• the methodology and approach on how they intend to meet the requirements listed in the case

study;

• their approach towards the composition of the project team: the personnel they intend to

allocate to each case study, the number of man-days for which they will be allocated, etc.;

• the internal and external communication procedures;

• the activities they intend to perform;

• the technical solutions envisaged;

• the envisaged timelines and content of outputs and deliverables (and potential artefacts);

• the envisaged quality assurance plan, covering the management of risks, change management

and software versions;

These descriptions should be technical and precise, focusing on the specific problems identified and

will serve as basis for the assessment of criteria 3 and 4.

21


Tenders scoring less than 60 % in the overall points total or less than 50% in the points

awarded for a single criterion will be excluded from the rest of the assessment procedure.

4.3.2 Price (P)

The price criterion (P) is evaluated as follows: a maximum of 30 points is given to the lowest price

offer. The other offers are ranked according to the following formula:

in which:

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P = (Pmin/Po) x 30

P = Classification of each price offer (points to be awarded)

Po = Price of each offer : total price as computed in Table 2 in section 3.3.3

Pmin = Minimum price offered among all tenders

30 = Maximum points to be awarded

The price offer (Po) shall refer to the total price as derived in Table 2.

4.4 Award of the contract and information to tenderers

4.4.1 Opening of tenders

The tenders received will be opened on 12/08/2008 at 14h00 in the Agency’s building at

Annankatu 18, 00120 Helsinki, Finland.

One authorised representative of each tenderer may attend the opening of the bids. Companies

wishing to attend are requested to notify their intention by sending e-mail at least 48 hours in

advance to reach-impl@echa.europa.eu. This notification must be signed by an authorised officer of

the tenderer and specify the name of the person who will attend the opening of the bids on the

tenderer's behalf. The Agency does not pay any expenses for this.

4.4.2 Information to tenderers

The Agency will inform tenderers of the outcome of the evaluation of this tender. If a written

request is received, the European Chemicals Agency will inform all rejected unsuccessful tenderers

of the reasons for their rejection and the name of the successful tenderer. However, certain

information may be withheld where its release would impede law enforcement or otherwise be

contrary to the public interest, or would prejudice the legitimate commercial interests of economic

operators, public or private, or might prejudice fair competition between them.

4.4.3 Conclusion of the contract

The procurement procedure may be concluded by a contract signed by the parties subject to the

terms and conditions as explained in section 2.9 of this document.

22


After the period of validity of the tender has expired, conclusion of the contract shall be subject to

the tenderer's agreement in writing.

The Agency reserves the right to conclude the contract in the form of a framework contract,

particularly in cases where the exact quantities and the precise timing of delivery or execution

cannot be specified in advance. A framework contract places reciprocal obligations on both parties

with regard to those elements which are unalterably and unequivocally established when the contract

is concluded, such as price, subject, basic performance conditions and duration.

4.5 Data protection

Any response to the invitation to tender will require the recording and further processing of personal

data (name, address, CV, for example). This data will be processed in accordance with the

requirements of Regulation (EC) 45/2001 on the protection of individuals with regard to the

processing of personal data by Community institutions and bodies and on the free movement of such

data. Except if mentioned otherwise, replies to questions and personal data are necessary for the

purpose of assessing a tender according to the specifications of the invitation to tender and will only

be processed by the Agency’s Data Controller for this purpose. A tenderer may, upon request, obtain

the communication of personal data and rectify any inaccurate or incomplete personal data. Any

queries concerning the processing of personal data should be addressed to the Agency’s Data

Controller. As regards to the processing of personal data, a tenderer has the right to recourse at any

time to the European Data Protection Supervisor.

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23


5. TECHNICAL SPECIFICATIONS

5.1 Background

5.1.1 General context

Under REACH regulation, manufacturers and importers of substances have a general obligation to

submit a registration dossier to the European Chemicals Agency for each substance manufactured or

imported in quantities of 1 tonne or more per year per company. Failure to register means that the

substance cannot be manufactured or imported into the EU.

Content of the registration dossier

Manufacturers and importers of substances will need to gather information on the environmental and

health properties of their substances, assess the risks arising from the uses of their substances and

ensure that these risks are properly managed. To demonstrate that this has been done, manufacturers

and importers need to submit:

• a technical dossier, for substances in quantities of 1 tonne or more per year, and, in addition,

• a chemical safety report, for substances in quantities of 10 tonnes or more per year.

The technical dossier 2 contains information on the properties and classification of a substance as

well as on uses and guidance on safe use. The information required to determine the properties of

the substances varies according to the tonnage in which the substance is manufactured or imported.

The higher the tonnage the more information on the intrinsic properties of the substance is required.

The information requirements are set out in the Annexes VI to XI of the Regulation.

For substances manufactured or imported in quantities starting at 10 tonnes, the Chemical Safety

Report (CSR) documents the Chemical Safety Assessment (CSA), consisting of the hazards

assessment, classification of the substance and the assessment whether the substance is persistent,

bioaccumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB). If the

substance is classified as dangerous or is PBT or vPvB, then an exposure assessment and risk

characterisation shall be performed to demonstrate that the risks are adequately controlled. This

exposure assessment is done using Exposure Scenarios (ES) for each use of the substance.

Exposure scenarios include operational conditions and risk management measures that identify and

document how substances are manufactured or used during their life-cycle and how the

manufacturer or importer controls, or recommends downstream users to control, exposures of

humans and the environment. Figure 1 depicts an overview on the different elements of the

chemicals safety assessment process.

2 It should be submitted using the IUCLID 5 format.

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24


IUCLID 5

16/06/2008 15:15

Figure 1 : Overview of the CSA process

In order to provide a tool for the chemicals industry to fulfil its obligations under REACH, a

software (also including a database) called IUCLID 5 (International Uniform Chemical Information

Database) has been developed. This new system, IUCLID 5 3 , enables industry to record and manage

on-site information on the properties of their substances and their effects on the environment and

human health and compile complete, REACH-conforming submission dossiers. It also enables the

European Chemicals Agency, the European Commission and the Member State Competent

Authorities to receive, further treat and manage industry submissions.

IUCLID 5 follows a standard data format (known as the OECD harmonised templates) for all

chapters related to the description and the reporting of studies on chemical substances. 87 templates

were developed related to the physico-chemical properties, the environmental fate, the ecotoxicity

and the toxicity of chemical substances. These provide IUCLID 5 a clear structure for all endpoint

sections and facilitate the exchange of information with other IT systems.

5.1.2 The Chemical Safety Assessment tool- generalities and context

Article 77 (2g) of the Regulation states that the Agency should provide guidance and tools, in

particular to assist the development of CSRs. Consequently the Agency has committed itself to build

3 IUCLID 5 can be downloaded from http://iuclid.eu

25


a tool to assist registrants and downstream users to carry out their CSA and to document the results

in their CSR.

Guidance on how to prepare an ES and how to make a CSA has been developed within a REACH

Implementation Project (RIP 3.2-2), led by the European Commission services, involving all

stakeholders: Member States, industry and non-governmental organisations. These documents

(called Guidance on information requirements and chemical safety assessment but herein after

referred as Guidance for Chemical Safety Report) have not been published yet as they are not

finalised. Nevertheless drafts can be found on the European Chemicals Bureau (ECB) website 4 .

The guidance consists of two major parts: Concise guidance (Part A to G) and supporting reference

guidance (Chapters R.2 to R.20). The total guidance volume of 1900 pages highlights the need to

develop a tool with a guided work process for the standard cases.

The purpose of the concise guidance is to provide guidance on the processes related to chemicals

safety assessment. This includes information collection processes, communication processes and

assessment processes. The purpose of the reference guidance is to provide in-depth scientific and

technical guidance when conducting the various parts of the chemical safety assessment.

The links between the concise guidance and the supporting reference guidance are outlined in Figure

2.

16/06/2008 15:15

Concise Guidance In Depth Guidance

A: Introduction

B: Hazard Assessment

R.2-R.7: Information Requirements

C: PBTand vPvB Assessment R.11: PBT/vPvB Assessment

D: Exposure Assessment

R.14-18: Exposure Estimation

E: Risk Characterisation R.19: Uncertainty Assessment

F: Chemical Safety Report

G: Extension of the SDS

Figure 2: Structure of the technical guidance document

R.8-R.10: Dose- or Concentration-

Response Characterisation

R.12: Description of Uses

R.13: Conditions of Use (RMM,OC)

R.20: Explanation of Terms

4 On http://ecb.jrc.it/reach/ go to the fan “document”, select “restricted access” and then select “SEG”.

The user name is “segr” and the password is “segr07”. Then select “IR CSA CSR GUIDANCE DRAFT MAR 2008”

26


Part A provides an introduction to the technical guidance document. This includes an overview on

the intended outcomes and main contents of the chemicals safety assessment (CSA). It also includes

the overall approach to making cost-effective decisions during the iterative process of conducting

the CSA, and a pathfinder to the different elements of this guidance. The communication and tasks

within the supply chain related to the chemical safety assessment are also outlined in part A. It

describes as well in more detail, in which situation an actor under REACH may need to carry out a

CSA.

Part B contains concise guidance on the hazard assessment. This covers the information

requirements on intrinsic properties of a substance under REACH, including information gathering,

non-testing approaches and the so-called 'integrated testing strategies' for generating the relevant and

required information on each endpoint. Part B also provides concise guidance on how to characterise

hazards, including where possible derivation of DNELs and PNECs. Each of the sections in Part B

corresponds to the more in-depth guidance contained in Chapters R.2 to R.10. This includes for

example:

DNEL derivation (or other qualitative or semi-quantitative measure of potency of the

substance) in Chapter R.8 and the corresponding chapters of integrated testing strategies for

the relevant human health endpoints (Sections R 7.2 to R.7.7). These sections in Chapter R.7

also include information on how to derive appropriate information for classification and

labelling of the substance. However, the guidance on classification and labelling itself is

provided elsewhere. See current Annex VI to Directive 67/548 and Guidance on

Classification, Packaging and Labelling related to the future GHS system.

PNEC derivation in Chapter R.10 and environmental exposure estimation in Chapter R.16

and the corresponding chapters of integrated testing strategies for the environment endpoints

(Sections R.7.8 to R.7.11 in R.7b and 7c). These sections in Chapter R.7 also include

information on how to derive appropriate information for classification and labelling of the

substance. However, the rules on classification and labelling themselves are provided

elsewhere. See current Annex VI to Directive 67/548 and Guidance on Classification,

Packaging and Labelling related to the future GHS system.

Part C contains the concise guidance on how to assess whether or not a substance is a persistent,

bioaccumulative and toxic substance (PBT) or very persistent and very bioaccumulative substance

(vPvB). In-depth guidance on the PBT and vPvB assessment is covered in Chapter R.11.

Part D details how to develop exposure scenarios and related exposure estimation. This part contains

detailed workflows on how to identify uses in the supply chain, how to develop exposure scenarios

and finalise them based on the iterations necessary for controlling risks. Part D provides links to

more in-depth guidance on exposure assessment, in particular how to describe uses, how to collect

information on operational conditions and risk management measures, and how to carry out

exposure estimates. This includes:

Brief general description of identified uses and giving exposure scenarios a short title

(Chapter R.12)

Risk management measures and operational conditions for building of exposure scenarios

(Chapter R.13)

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27


Exposure estimation related to workers, consumers and the environment (Chapter R.14-18)

Chapter R.20 contains a table of terms in which the terms that are essential for the

understanding of the CSA guidance are defined (to be linked later on to the ECHA website)

Part E contains the guidance on the risk characterisation. In the risk characterisation, information on

hazard and exposure is combined in the risk characterisation ratio or in qualitative risk

characterisation. Both types of information contain uncertainty which needs to be assessed in order

to decide on the robustness of the risk estimate. The uncertainty analysis is further detailed in

Chapter R.19. Part E contains an appendix on qualitative risk characterisation with regard to non

threshold substances.

Part F details the format and requirements for preparing the chemical safety report, which

documents the results of the entire chemical safety assessment. Part F details subsections to the main

headlines as laid down in section 7 of Annex I of REACH and provides guidance on how to present

the outcome of the CSA.

Part G contains the guidance on preparing the extensions to the safety data sheet (SDS). This

contains information on how the exposure scenario is communicated and implemented in the supply

chain.

The chemical safety assessment tool is meant to support industry in following the core elements of

the guidance when carrying out the CSA for standard cases.

Its main features are to:

• allow the use of data reported in IUCLID 5 on the substance properties

• support the registrant’s work on building and recording its exposure scenarios

• allow exposure estimation and risk characterisation

• support the user in documenting control of risk in its CSR

• support the user to prepare the ES which should be attached to the Safety data sheet

(extended SDS)

In order to further analyse and describe the stakeholders’ requirements, an expert group was put in

place in November 2005 and a discussion paper on development of IT tools was published in July

2006 on the European Chemicals Bureau (ECB) website 5 .

5 On http://ecb.jrc.it/reach/ go to the fan “document”, select “public access” and then select “RIP FINAL

REPORTS > RIP 3.2-2 CSA-CSR MAIN > TASK III IT TOOLS SUPPORTING CSA-CSR

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Within RIP 3.2-2 an initial analysis of IT tools for exposure scenario has been performed

(November 2005 - June 2006) and a report is available on ECB website 6 .

This work was used in a subsequent project on “Study on IT tool to assist the development of

Chemical Safety Reports” (hereinafter referred to as the “analysis and design project”). This later

project ran from April 2007 to March 2008. Its objective was to analyse the requirements for a

CSA/CSR IT tool and prepare analysis and design models which could be applied for the subsequent

build of the IT tools supporting the process of generating exposure scenarios, carrying out chemical

safety assessments and generating the respective chemical safety reports.

5.1.3 Analysis and design project: Study on IT tool to assist the development of Chemical

Safety Reports

All the deliverables from this project are available on DG ENTR website

http://ec.europa.eu/enterprise/reach/reach_studies_en.htm.

5.1.3.1 Deliverables of the analysis and design project

The core documents from this project are the following:

Vision Document

This document describes the vision of the project, based on input from RIP 3.2 and stakeholder

requests (see next document) specified in terms of key needs and features. It follows the

requirements for the CSA and CSR described in Annex I and XII of REACH. It contains an outline

of the envisioned core requirements, and it provides the basis for the more detailed technical

requirements. The document allowed the identification of preliminary building blocks for the tool.

Stakeholder requests and updated requests

This document identifies the stakeholder user (customer, end user, etc.) and system requirements

applicable to the system to be developed. It also captures system requirements that are not readily

captured in behavioural requirements documents such as use-case specifications.

Use Case Model

The purpose of this document is to derive system requirements specifications from expressed user

needs related to a future information system to support tasks resulting from the chemical safety

assessment and reporting process.

6 On http://ecb.jrc.it/reach/ go to the fan “document”, select “restricted access” and then select “SEG”.

The user name is “segr” and the password is “segr07”. Then select “RIP 3.2-2 CSA-CSR IT TOOLS”, “WORKING

DOC 3.2-2 TASK IV CONTRACTOR” . “071121 IT Tools.pdf”

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29


This document provides a description of the system specifications in terms of actors and use cases, a

standard way to translate and organise the understanding of stakeholder needs into a meaningful

description of the system to be built.

Use Case Specification

A use case description defines a set of use-case instances, where each instance is a sequence of

actions a system performs that yields an observable result or value to a particular actor. In other

words, use cases are specified as sequences of actions that the system can perform. This analysis

main document translates the scope of the short term vision, delivered by the RIP 3.2. It therefore

describes the functionalities of version v.1.0 of the future CSA application.

It describes the front-end (user interface) and back-end (server side) functionalities of the future

CSA application as well as the functionalities expected from the external applications interacting

with it. Taking into account the complexity of the domain and the critical timing the analysis has

focused its efforts on

• refining the concepts expressed by the RIP 3.2-2, especially its workflow,

• capturing the key use cases and functionalities, according to a pragmatic approach in the

building of the exposure scenarios, the chemical safety assessment and the generation of the

chemical safety report.

The external CSA tool applications have been taken into account according to the recommendations

of RIP 3.2. Accordingly, the analysis goes beyond their simple mention and defines, from the CSA

point of view, the functionalities that are expected from them, even if they may need adaptations in

order to provide the particular logic from their side (not in the scope of this study).

Software Architecture

The Software Architecture document provides an architectural overview of the system. This

document contains an analysis of the system architecture of existing tools (EUSES, ECETOC TRA,

etc.), and of the advantages or drawbacks of having a single integrated tool compared to a set of

independent and smaller tools.

At the analysis level, keeping in mind of not forcing a technically not feasible implementation, the

software architecture defines the functional application modules to be developed and later

technically translated.

Analysis Model

An Analysis model describes the realisation of use cases, which serves as an abstraction of the

Design model. The scope of this document is limited to the description of the main information

classes and elements and should not be used without the other documents of the Analysis. It

describes:

• a context description from the functional use case packages,

• the main information classes and composing elements,

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5.1.3.2 Description of the functionalities of version v.1.0 foreseen in the project

5.1.3.2.1 Introduction

During the analysis and design project it has been identified that the tool could offer the following

functionalities to the user in the so called version v.1.0 (see description of the Use case specification

in section 5.1.3.1):

• A guided, stepwise process of ES building, including exposure estimates and risk

characterisation. Iteration of this process should be possible.

• Import and export of data (values and text) between a so-called ES work template (see

5.1.3.2.2 (2)) and IUCLID 5, exposure estimation tools, Risk management measures (RMM)

libraries, the CSR and the extended Safety Data Sheet.

• An option to start ES building from:

o a pre-set of potential relevant factors that determines the exposure and corresponding

default values triggered by the brief general description of identified uses;

o already existing ESs. In this case if the same ES is relevant for any other use than the

one it had initially being developed for, it would be possible for the user to broaden

the scope of the ES by modifying its title and description of activities covered.

• Editing of the CSR and the ES annexes for the SDS.

The tool will not, in its first version, support hazard assessment including derivation of DNELs

(Derived no effect levels). This information for the CSR is imported from IUCLID 5 without further

processing in the CSA tool. Thus the hazard assessment takes place outside the tool, and the relevant

results and justifications are stored in IUCLID 5.

5.1.3.2.2 Elements of the CSA tool

An ES work template should be defined in the application, in order to store the relevant information

• to process the CSA,

• to be reported in the ES attached to the SDS or incorporated in the CSR.

This is based on the ES format developed in Part D of the of the Guidance for Chemical Safety

Report.

A more detailed CSR template (including the ES sections) is under development. When available (a

draft is circulated for REACH CA endorsement at the meeting of 16 June 2008) it will be made

available on the Agency website (http://echa.europa.eu/opportunities/procurement_en.asp)

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1. Overview of uses

The brief general description of uses in IUCLID 5 is based on 4 standard descriptors 7 :

i. The Process Category (PROC) which corresponds to the application type (= process type). 8

ii. The Preparation Category (PC) which describes the substance function and the type of

preparations in which the substance is used.

iii. If relevant, the Article Category (AC) into which the substance is processed.

iv. The Sector in which the substance is Used (SU).

For each exposure scenario to be developed it could be possible to start with the identification of the

appropriate combination of those descriptors.

The default process, preparation and article categories for which exposure estimates can be derived

with an exposure estimation modelling tool, will be flagged 9 .

2. Exposure Scenario Work Template

This section describes the information that needs to be stored within the CSA tool in order to allow

chemical safety assessment (through exposure estimation and risk characterisation) and to enable

appropriate reporting in the CSR and in the annex to the SDS.

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a) Short title and description of activities

The ES contains 2 different types of information:

• Short title of the ES and activities covered (section 1 and 2 of the ES template described in

part D of the Guidance for Chemical Safety Report)

• Operational conditions of use, risk management and waste management determining

exposure for that use (section 3 to 7 of the ES template).

7

In the next update of IUCLID 5 the descriptor will be adapted to the descriptor system described in the RIP 3.2

Guidance and used in this document.

8 For the moment this is still a free-text field in IUCLID 5 called application technique/activity but the registrant can use

the pick-list of process categories (PROC) from the RIP 3.2 guidance.

9 This description is provided as a potential implementation in order to provide better understanding of the way the

application functions. The details of such concrete implementation (usage of tables, …) has to be taken into account for

the ergonomic and the graphical user interfaces as part of the build project.

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At the beginning of the ES building process, a preliminary short title of the ES can be assigned by

selecting one or more cells from overview of the uses. The preliminary title will be converted into a

final title, once the assessment process has been finalised.

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b) List of potential operational conditions (OC), Risk management measures (RMM)

and waste management measures (WMM) determining exposure

The tool will take into account a full list of potential factors that determines the exposure (so called

determinants). Two types of determinants can be differentiated:

• For some of the determinants preset pick-lists and values are displayed, triggered by the

choice of process or preparation or article category.

• For determinants that cannot be addressed in the existing exposure assessment tools only free

text fields are displayed. The justification on whether and how the OC, RMM and/or WMM

have been taken into account in the exposure assessment will have to be documented.

The OC, RMM and WMM to be compiled for the initial ES are based on all information available to

the registrant. The list of potential determinants is meant to support the registrant in converting the

available information into a more standardised form for the ES building.

The registrant can make his choice, whether the relevant OC, RMM and WMM can be expressed by

the default determinants linked to available exposure estimation tools or whether the exposure

assessment needs to be carried out manually because the use/conditions of use are outside the

boundaries of the available tools. If he carried out the estimation by one of the available tools the

following options should exist in the tool:

• The registrant makes his choices among the displayed parameters for the determinants

covered in the selected tool.

• The registrant documents that he has made himself aware that none of the other potential

determinants may have relevant impact on exposure (ticking taken/not taken into account

with a short justification).

• The substance properties are imported from IUCLID 5 into the tool.

• The application displays a warning if the boundaries of a tool and the hazard profile of a

substance do not match.

3. Exposure estimation table

Two separate exposure estimation tables are foreseen for each ES:

• estimated exposure concentration obtained by modelling,

• measured exposure concentration related to the ES.

The input to the tables may be fed by:

• the output from the exposure estimation tools (directly connected to the application).

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• the results of any other modelling based exposure estimation with appropriate documentation

of the modelling method, including iterations of the determinants in the exposure estimation

tools originally not foreseen in the available tool.

• measured exposure (with statistical background) and consistent reference to the OC, RMM

and WWM described under 2.b).

4. Risk characterisation

The application should also support the allocation of suitable DNELs or PNECs (Predicted no effect

concentration) to the exposure concentration for the purpose of risk characterisation. As explained in

section 5.1.3.2.1 hazard assessment, including derivation of those DNELs/PNECS will not be done

within the application for the first versions of tool. They will be reported and stored in IUCLID 5

and imported from IUCLID 5 to the application.

Based on the exposure estimates it may turn out that certain DNELs/PNECs are not available in

IUCLID 5 yet. This may potentially lead to further derivation of DNELs based on available

endpoint information outside the application.

Risk characterisation should be carried out within the application and reported in risk

characterisation tables

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a) Risk Characterisation table per ES

• displays the risk characterisation ratios per exposure route within one ES,

• displays the risk characterisation ratio (RCR) for combined exposure within related to the

same ES,

• allows to determine whether and to which extent iteration is needed.

b) Combined exposure across different ES (adding RCRs)

Once the RCRs have been assessed for all ES and that no risk is identified for all individual ES,

combined risks still need to be assessed and this could be supported by the application letting the

user proceed with combination for:

• Environment from different product/process types,

• Consumer from different types of product,

• Consumer plus man indirect,

• Consumer exposure and occupational exposure 10 .

10 This may only be relevant in very specific cases; where combined exposure across ESs indeed is relevant. It could be

decided to add an overall ‘man indirect’ across all ESs (i.e., based on overall tonnage) as ‘background’ to consumer or

worker exposure for each individual ES.

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5. Additional information for the Downstream User (DU) in the ES

In communicating the exposure scenario to the DU, some additional information may be needed to

facilitate the communication mechanisms in the supply chain as foreseen by REACH. The ES

format suggested in part D of the Guidance on Chemical safety report contains a section 8 and a

section 9 to provide the following information to the DU:

• Exposure estimate for each ES, including a reference tool or methodology applied to derive

the exposure estimate.

• Guidance to demonstrate work within the boundaries of the ES.

This type of information is however not required in the ES sections of the CSR.

6. Documentation and storage

Each section in the template may contain the following types of information. It is envisaged that

each field includes already a classification whether/where the information

• is documented in the CSR,

• becomes part of the eSDS and/or

• is to be stored in IUCLID 5.

This information would be:

• Values,

• Pick-lists of standard phrases (e.g. for OC or RMM),

• Free text field for not yet standardised phrasing,

• Justification and comments.

5.2 Objective of the contract

This contract is being set up to develop and build a tool to assist registrants and downstream users in

the preparation of Exposure Scenarios and Chemical Safety Assessment as well as Chemical Safety

Report. This tool could also be expanded to support the authorities when preparing Annex XV

dossiers. All activities necessary to carry out this main objective and deliver a tool to the scientific

and industrial community shall be covered under this contract as detailed in section 5.6.

5.3 Project timing

The first registration deadline for substances already manufactured or imported (the so called phasein

substances) in high tonnage (above 1000 tonnes per year) or having very hazardous properties is 1

December 2010. It is therefore assumed that a high number of registrants will need to finalise their

16/06/2008 15:15

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egistration dossier in 2010. As a consequence it is planned to have a tool available to support this

work no later than September 2009.

As there are around 200 functionalities in the version v.1.0 of the application, which are described in

the “Use Case Specification” document (see section 5.1.3.1), the tool to be implemented is a large

and complex application. Therefore not all the envisaged functionalities can be included in an

operational release before summer 2009, and it is foreseen that under this contract several versions

of the CSA tool will need to be developed and released at different points in time.

A first operational version v.0.1 of the tool has to be released (tested and accepted) at latest in

September 2009. This version should cover the main functionalities that are essential for the

registrants.

All the functionalities described as version v.1.0 have to be included into the next operational

release (built, tested and accepted) early 2010.

Further elaboration and development of the tool will take place later on. This will for example

comprise:

• Link with risk management measures databases,

• Refined exposure assessment using Tier 2 models,

• Possibility of preparation of substance evaluation by the authorities,

• Possibility for preparation of Annex XV dossiers by the authorities.

5.4 Project planning

A detailed planning will have to be set up for the project.

This planning should cover all the phases of the project:

• Elaboration of the specification and design of the tool in addition to the specifications

described in the ‘analysis and design’ project,

• Build phase,

• Test phase, including testing with stakeholders (industry and member states, as described in

the section below),

• Deployment phase, including training and presentation during workshops.

5.5 Project organisation

The Agency will nominate a project manager who will manage this contract and will be the main

contact person for the contractor unless otherwise indicated. The project manager will be supported

by a project team within the Agency.

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The project language is English. All deliverables in the context of this project must be drawn up in

English.

5.5.1 Stakeholder consultation

Main stakeholders, industry, national authorities and the Commission will be consulted during the

project. For that purpose a small expert group will be set up by the Agency. This group should be

used as an advisory group for the project but also for contributing to other tasks such as testing.

Meetings will be organised for this consultation process by the contractor (in its premises or the

Agency premises, to be decided by the Agency after consultation of the projects managers of both

sides). Documentation, prototypes or any other type of information will have to be prepared by the

contractor for that purpose and agreed by the Agency in advance of these expert meetings. Details

will be further defined in the specifications for the specific contracts.

5.5.2 Meetings, minutes and deliverables

Each specific contract under this framework contract will be started with a kick-off meeting, which

will take place in Helsinki or any other location as requested by the project manager of the Agency.

Depending on the size and complexity of the project, regular project meetings will take place during

the lifetime of a specific contract. The frequency of meetings and their location will be determined

by the Agency at the time of “request for proposal” (see Annex III of the draft framework contract,

which explains the order process for specific contracts in detail).

Reports should be provided electronically in appropriate format (eg. Word, Excel, Oracle, html, pdf

etc) and should be written in clear English. The final report needs to be provided within the deadline

stated in the specific contract.

The draft minutes of all meetings will have to be written by the contractor. Meeting minutes, which

have been agreed with the Agency project team, will form part of the deliverables.

The format of possible deliverables can vary considerably and will depend on the content of the

specific contract. The format of all deliverables will be specified at the time of “request for

proposal”. As examples, the deliverables could be in the form of (non exhaustive list):

• reports (draft and final)

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• functional specification documents(drafts and final);

• User manuals

• Documented source code

• Installable software packages (prototype(s), different version releases)

• Workshops or training sessions accompanied by appropriate written material and

presentations;

• Testing plans

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• Project plans

• Quality plans

The European Chemicals Agency project manager may request at any time information about the

progress of the project and drafting of the reports. The contractor is required to maintain frequent

and regular contacts with the European Chemicals Agency Project team.

5.6 Profiles

For each profile type described below an indication is provided with regard to the expected “usage”

of the profile under this framework contract. However these indications are estimated by Agency

based on the current perception of the project, the actual use may differ:

1. Project Manager

Scientists profiles

2. Senior scientist

3. Junior scientist

IT profiles

4. Quality Consultant

5. User Requirements Analyst

6. Senior Analyst Programmer

7. Programmer

8. Junior programmer

9. Technical writer

10. Web designer-developer

11. Web developer

For each of these profiles the following information regarding requirements is provided:

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Nature of the tasks These are examples of the tasks that will be expected of a person

proposed with the required profile. This list is not exhaustive and is to

be regarded as an indication.

Education A description of the minimal educational qualifications that are

required for the profile.

Knowledge and A list of the minimal knowledge and skills that a person with this

38


16/06/2008 15:15

skills profile is expected to possess.

Experience The required experience for the profile.

5.6.1 Project Manager

Nature of the tasks o Project management including proposals for project strategies,

planning, definition of tasks and deliverables, review of project

deliverables, quality control, risk analysis and management, status

reports, problem reporting and management systems, follow up and

organisation.

o Guide sub-contractors in charge of project activities and review

their deliverables.

o Participate in functional and technical working groups and progress

meetings.

o Estimate costs, timescales and resource requirements for the

successful completion of each project to agreed terms of reference.

o Prepare and maintain project and quality plans and tracks activities

against the plan, provide regular and accurate reports.

o Monitor costs, timescales and resources used, and take action where

these deviate from agreed tolerances. Ensure that delivered systems

are implemented within these criteria.

o Manage the change control procedure gaining agreement for

revisions to the project from project sponsors.

o Provide effective leadership for the project team ensuring that team

members are motivated and constantly developing their skills and

experience.

Education o University degree, in a relevant subject.

Knowledge and

skills

Experience

o Project management.

o Usage of project management tools.

o In depth technical knowledge of the project’s main aspects.

o General technical knowledge on the other aspects touched by the

project.

o Usage of methods and techniques for reporting.

o Ability to give presentations.

o Ability to apply high quality standards to all tasks in hand, no

matter how small, and ensuring that nothing is overlooked.

o Ability to participate in English-only meetings, good

communicator.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working, understanding the needs, objectives and constraints of

those in other disciplines and functions.

o Leadership capability.

o Minimum 8 years experience of managing successfully IT projects

of comparable size. Practical hands-on experience with most stages

of the system development life-cycle is desirable.

o Experience with a project management tool.

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o Proven experience with quality procedures.

5.6.2 Project Assistant

Nature of the tasks o Support to the project leader/manager in administrative and

communication issues

Education o Office Management and Communication

Knowledge and

skills

Experience

o Good knowledge of MS office software

o Good communicator in following up timelines and agreements

o Skills in organising meetings (including all administrative tasks)

o Usage of project management tools

o Ability to participate in English-only meetings, good

communicator.

o Ability to write minutes of meetings

o Minimum 3 years experience of successfully supporting IT projects

of comparable size.

5.6.3 Senior scientist

Nature of the tasks o Analysis of user requirements

o Detailed description of the scientific methodology to be described

by the application

o Preparation of user manual for the application.

o Training on the tool

Education o University degree, in a relevant subject.

Knowledge and

skills

Experience

o Ability to perform a risk assessment: in depth knowledge of the

methodology as well as of existing tools

o In depth knowledge of the Guidance on information requirements

and chemical safety assessment developed for REACH

o Experience in design and evaluation (of efficacy) of risk

management measures at workplaces and/or industrial sites

(environment) and/or product level.

o Ability to participate in English-only meetings, good

communicator. Ability to give training.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Minimum 7 years of experience in chemical risk assessment.

5.6.4 Junior scientist

Nature of the tasks o Analysis of user requirements

o Detailed description of the scientific methodology to be described

by the application

o Experience in design and evaluation (of efficacy) of risk

management measures at workplaces and/or industrial sites

(environment) and/or product level. (if not covered by the senior)

o Preparation of user manual for the application.

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Education

Knowledge and

skills

Experience

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o Training on the tool

o University degree, in a relevant subject.

o Ability to perform a risk assessment: in depth knowledge of the

methodology as well as of existing tools

o Knowledge of the Guidance on information requirements and

chemical safety assessment developed for REACH

o Ability to participate in English-only meetings, good

communicator. Ability to give training.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Minimum 4 years of experience in chemical risk assessment.

5.6.5 Quality consultant

Nature of the tasks o Consultancy studies on quality matters regarding information

systems and IT processes.

o Assistance and support with the preparation and validation of

quality plans for building and maintaining information systems.

o Assistance and support on service level agreements or other quality

documents associated with information system projects.

o Coaching on quality assurance regarding information systems and

IT processes.

o Carrying out quality audits and IT processes quality assessments.

Education o University degree, in a relevant subject.

Knowledge and

skills

Experience

o Ability to participate in English-only meetings, good

communicator.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Capability of applying formal quality standards in the IT

environment.

o Quality management, quality models, IT quality assurance (ISO

standards, guidelines and references of other organisations…).

o Experience in carrying out high-level management studies.

o Quality assurance of IT projects.

o Minimum 5 years in Quality Assurance, of which minimum 2 years

experience in IT Quality Assurance.

5.6.6 User requirements analyst

Nature of the tasks o Production of user requirements for new information systems in a

form understandable for both users and technical persons

developing/maintaining the information system.

o Interface between users and the technical team

Education

developing/maintaining the information system.

o University degree, in a relevant subject.

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Knowledge and

skills

Experience

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o Ability to participate in English-only meetings, ease of

communication.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Diplomatic.

o Having a good balance between technical and interpersonal skills.

o Minimum 5 years in IT, of which minimum 2 years experience with

requirements analysis.

5.6.7 Senior Analyst-Programmer

Nature of the tasks o Detailed analysis of new user requirements.

o Prototyping.

o Write/maintain programs that reflect the specifications based on

user requirements.

o Assist with the testing of such programs together with the other

programs making up the system.

o Produce the relevant technical documentation and documentation

for the support team.

o Assist the support team with training the users of the system.

o Assist with evaluating and testing products delivered by external

system suppliers.

o Participation in meetings with the users.

Education o Successful training in informatics by a competent institute.

Knowledge and

skills

Experience

5.6.8 Programmer

Nature of the tasks

o Ability to participate in English-only meetings, ease of

communication are assets.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Minimum 10 years experience in IT, including 5 as analystprogrammer.

o Experience with CASE tools.

o 5 years of programming experience in the programming languages

relevant for the application.

o Experience in multi-client environments.

o At least 3 year of experience with multi-user SQL-based databases.

o Preparation of diagrams.

o Writing/maintaining programs in different programming languages.

o Preparation and execution of test programs.

o Technical documentation.

o Optimising procedures.

o Preparation of scripts for data base migrations.

o Preparation for scripts for application installation (to be used by

support team).

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Education

Knowledge and

skills

Experience

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o Successful training as a programmer by a competent institute.

o Ability to participate in English-only meetings, ease of

communication in technical matters are assets.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o 3 years of programming experience in the programming languages

relevant for the application.

o At least 3 year of experience with multi-user SQL-based databases.

5.6.9 Junior programmer

Nature of the tasks o Preparation of diagrams.

o Writing/maintaining programs in a specific programming language.

o Preparation and execution of test programs.

o Technical documentation.

o Optimising of simple procedures.

o Preparation of scripts for simple data base migrations.

o Preparation of scripts for application installation (to be used by

support team).

Education o Successful training as a programmer by a competent institute.

Knowledge and

skills

Experience

o Ability to participate in English-only meetings, ease of

communication in technical matters are assets.

o Willing to integrate in an international/multi-cultural environment,

and willing to work in a team.

o Less than 2 years of programming experience.

o Successfully completed training for the programming languages

relevant for the application

5.6.10 Technical writer

Nature of the tasks o Writing technical documentation regarding information systems

Education

Knowledge and

skills

Experience

o Training on the general aspects of information technology and

information systems.

o End-user training on the office automation tools used by the

Agency (MS-Office).

o Successfully completed training on drafting skills at a specialised

institute.

o Ability to participate in English-only meetings, ease of

communication in technical matters are assets.

o Capability of integration in an international/multi-cultural

environment, rapid self-starting capability and experience in team

working are mandatory.

o Excellent writing skills are required.

o Able to use the office automation tools used by the Agency (MS-

Office).

o Minimum 2 years experience in IT.

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5.6.11 Web designer-developer

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o 2 years of documentation authoring experience, of which 1 year of

technical documentation authoring.

o Minimum 1 year of experience with the office automation tools

used by the Agency (MS-Office).

Requirements as a senior analyst-programmer and in addition:

Nature of the tasks

Education

Knowledge and

skills

Experience

5.6.12 Web developer

Requirements as a programmer and in addition:

Nature of the tasks

Education

Knowledge and

skills

o Definition of the logical and physical structure of web sites and web

pages.

o Definition of navigation methods.

o Definition and integration of the various required technological

components.

o Development of complex web-enabled applications, from front-end

to back-end systems.

o Creation of distributed applications for internet/intranet

environments.

o Successful training at a specialised institute on the products used

for web development at the Agency.

o Able to cope with the fast changing technologies used in web

development.

o Strong interest in follow-up of trends in web development.

o Able and willing to follow the Commission guidelines regarding

internet/intranet development.

http://europa.eu.int/comm/ipg/index_en.htm

o Conceptual understanding of content structuring, storage, access

and presentation elements.

o Able to cope with the needs of multi-language site design.

o Minimum 3 years of web development experience.

o Development of web-enabled applications.

o Creating/maintaining applications for internet/intranet

environments.

o Development of front-ends.

o Development of back-end systems.

o Successful training at a specialised institute on the products used

for web development at the Commission.

o Able to cope with the fast changing technologies used in web

development.

o Strong interest in follow-up of trends in web development.

o Able and willing to follow the Commission guidelines regarding

internet/intranet development:

http://europa.eu.int/comm/ipg/index_en.htm

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Experience

5.7 Coverage of the contract

5.7.1 Analysis of requirements

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o Minimum 3 years of web development experience.

It is expected that in addition to the guidance on chemical safety report and the “analysis and

design” project further scientific analysis on how to develop exposure scenarios and perform a

chemical safety assessment is required for this project in order to describe the specifications for the

tool at a sufficient level of detail for IT programming. This analysis should be made based on the

existing documents prepared during the “analysis and design project” (see section 5.1.3).

In addition, in order to allow the development of the different modules of the tool in successive

steps, prioritisation of user requirements is essential. This prioritisation should be made taking into

account both the relevancy for the users and the technical IT implementation possibilities. The

contractor will have to come up with suggestion for prioritisation (see also Case study 2, in section

5.8.2) and the specific requests to the contractor based on decisions made by the Agency will be

done through the specific contracts.

In the second development phase (after version v.1.0 has been implemented, see section 5.3), the

additional functionalities of the application will have to be further analysed, in particular to extend

the scope of the application to the preparation of Annex XV dossier or substance evaluation reports

by the authorities.

5.7.2 System Analysis & Design, Implementation, Testing, Deployment and

Maintenance 11

After the analysis of the requirements phase the contractor will have to define the software

development process and the software's overall structure developing a plan for a solution. It should

include low-level component and algorithm implementation issues as well as the architectural view.

The proposed solution must correspond to an extensible, robust, reliable, fault-tolerant, secure,

maintainable, interoperable with another products, modular and reusable system.

Based on the software architecture and design the contractor will have to implement a WEB-based 12

3-tier application that can be installed and work properly with any of the following combinations in

11 Due to the nature of the particular project (consecutive operational releases) a flexible software development model

should be considered so that it will allow reacting to changes in requirements and emphasising on obtaining the smallest

workable piece of functionality to deliver business value early, and continually improving it /adding further functionality

throughout the life of the project.

12 The tool will be used by a very large community of manufacturer, importers or downstream users of chemical

substances. It can be estimated that around 30-35 000 registration dossiers will contain a CSR (corresponding to around

10 000 substances. It should be noted that some companies will register a high number of substances, therefore the

number of dossiers do not correspond to the number of users of the tool. It can nevertheless be expected that in those

companies, several users will have to use the tool.). In order to be able to develop ES, assess the safety of the chemical

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a stand-alone or a distributed environment (for example, the database and the application server are

installed at different physical/virtual servers):

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* Operating system: Microsoft Windows XP and Vista, Linux, Solaris

* Database: Oracle®, PostgreSQL, MySQL

* WEB Server: Apache

In case that Java is going to be used as the underlying technology then:

* Application Server: BEA WebLogic Server®, Apache Tomcat

The users should be able to access the tool using any modern WEB browser. Indicatively are

mentioned: Internet Explorer version 7 or later, Mozilla Firefox version 2.

For user access rights purposes the tool must be configurable so that it either uses the local database

for new users or an existing Directory server using LDAP protocol.

Thorough testing of each new release has to be conducted by the contractor in order to verify that the

software that will be delivered for acceptance meets its specifications and all development activities

are completed.

In order to facilitate the deployment of the tool the contractor will have to provide automated

mechanisms that allow the installation and un-installation of new versions of the application and the

update of existing ones.

A version control system has to be used – preferably Subversion (SVN) – in order to keep current

and historical versions of files such as source code, web pages, configuration files, software

releases, setup kits, and documentation. The version control system should be accessible by the

Agency staff using username/password security.

As it was mentioned before, consecutive operational releases of the application are expected starting

with version v.0.1. The contactor might be requested to maintain them so that faults are corrected,

performance and/or other attributes are improved or the application is adapted to a modified

environment.

5.7.3 Communication and training activities

In addition to the scientific development and IT implementation of the CSA tool, the tenderer should

be able to cover the following activities:

and prepare a CSR, a certain level of expertise is required on chemical properties assessment, exposure assessment and

risk assessment in general. Nevertheless it can be foreseen that the level of expertise will be very wide. Therefore, it is

very important that the user interface is designed in a user-friendly way and it guides clearly the users at the

various steps they have to follow.

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• Presentation of the development of the tool during its implementation to various stakeholders

during expert meetings. Discussion and comments during those meetings will have to be

taken into account in agreement with the Agency.

• Provide training on the tool.

5.8 Description of case studies

In this section the case studies for consideration for award criteria 3 and 4 of the contract award

stage (see section 4.3) are described.

5.8.1 Case study 1: Exposure scenario generation

In the “use case specification” document (see section 5.1.3.1) the functionalities for the development

of ES are described in the Functional Process (FP) 1.1 and 1.2. The objective is to generate an initial

ES and iterate it as necessary (See description of ES work template in section 5.1.3.2.2) so that:

• relevant and appropriate determinants are identified so that exposure estimation can take

place,

• relevant and appropriate description of operational conditions and risk management

measures are documented so that they can be reported in the ES to be communicated down

the supply chain and documented in the CSR.

The link between the description of the risk management measures in place and the exposure

estimation is critical for the tool. For an initial assessment the use descriptors as described in the

Guidance on chemical safety report (see chapter D and R12) will be the basis for the identification

of the key determinants.

The objective of this case study is to present an approach for the development of the IT module for

the generation of ES (initial generation and iteration). The link with the exposure estimation is

included in the case study but the exposure estimation itself as well as the risk characterisation is not

part of the case study. It should also be explained how the risk management component and the

downstream user feedback component in ES development can be supported by the tool.

The study should contain a description of the approach for developing ES, including clear support

for the user on the steps to take (workflow). As stressed before it is expected that the level of

expertise of the users will be variable. Therefore, it is very important that the user interface is

designed in a user-friendly way and it guides clearly the users at the various steps they have to

follow. The user interface aspects should be demonstrated and illustrated with mock up screens.

In addition, the underlying technologies that could be used to in order to implement the particular

module (all technical aspects) have to be defined and analysed.

5.8.2 Case study 2: First version of a CSA tool

The “use case specifications” document (see section 5.1.3.1) describes the functionalities of a socalled

version v.1.0. The functionalities included in that version have been identified during the

analysis and design project as covering most of the necessary functionalities for such a tool.

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Nevertheless it will be necessary to develop the tool in several steps and to include those

functionalities gradually in order to meet time-lines for the release of the tool (see section 5.3).

The objective of this case study is to describe what functionalities could be included in an

operational release of the tool nine months after the beginning of the contract. In their proposal the

tenderers should justify the coherence of the product that could be delivered in this time frame and

explain the rationale of choosing the particular functionalities. The choice should also be explained

in relation to general work plan for the build of the complete version v.1.0.

The functionalities, which are going to be implemented the first nine months of the lifecycle of the

project (subset of the v.1.0 version of the application), must be reasonable from scientific point of

view. The justification of their selection is considered very important and it should take into account

the technological constraints. In addition, their link to the scientific selection of those functionalities

should be demonstrated.

The key features for optimising the project organisation, in order to meet the timing constraints,

must be portrayed as well.

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6. TERMINOLOGY AND ACRONYMS

More definition and acronyms can be found on the Agency website (in http://reach.jrc.it/, click

glossary on the top right)

Brief general description of use: Description of identified uses in the registration dossier (Annex

VI of REACH Regulation, point 3.5).

CSA: Chemical Safety Assessment

CSR Chemical Safety Report

Determinants of emissions and/or exposure: Factors determining the exposure and or release

when a substance is manufactured or used (including the subsequent life cycle stages (service life

and waste disposal). These factors include the characteristics of the substance, the operational

conditions of use and risk management measures.

DNEL: Derived No Effect Level. A DNEL is the level of exposure to the substance below which

no adverse effects are expected to occur. It is therefore the level of exposure to the substance above

which humans should not be exposed. DNEL is a derived level of exposure because it is normally

calculated on the basis of available dose descriptors from animal studies such as No Observed

Adverse Effect Levels (NOAELs) or benchmark doses (BMDs).

DU: Downstream Users

Environmental release categories: A pre-set combination of life cycle stage, distribution of

emission sources, fate of substance in the technical process, level of containment and risk

management measures, typical for an identified use.

ES: Exposure Scenario

eSDS: extended Safety Data Sheet

Final exposure scenario: The final ES is developed from the initial ES, and describes the

operational conditions and risk management measures suitable to control the risks in an identified

use (or a group of uses) of a dangerous substance.

Initial exposure scenario: The initial ES describes the current conditions of use based on

information readily available to Manufacturer or Importers when starting the chemical safety

assessment for the identified use (or groups of uses) for a dangerous substance.

OC: Operational Conditions: All conditions which have a quantitative impact on exposure, e.g.

product specifications, duration and frequency of exposure, applied amount of substance per use or

capacity of surroundings (e.g. room size, receiving environmental compartment).

PNEC: Predicted No Effect Concentration. Concentration of the substance below which adverse

effects in the environmental sphere of concern are not expected to occur.

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RCR: Risk Characterisation Ratio

RMM : Risk Management Measures: Technical and/or organisational measures to ensure control

of risks during manufacturing and use of substance as such, in a preparation or an article.

SDS: Safety Data Sheet

Short title of exposure scenario: Describes the uses and/or subsequent life cycle stages of a

dangerous substance addressed in an exposure scenario. The short title of the ES should be

consistent with the brief general description of use (see Annex I of REACH Regulation, point 5.1.1).

Use and exposure categories: Means an exposure scenario covering a wide range of processes or

uses, where the processes or uses are communicated, as a minimum, in terms of the brief general

description of use (REACH Article 3 (38)).

Use descriptor system: Set of four descriptors which can be used i) to briefly describe identified

uses in a brief general way and ii) to build the short title of an exposure scenario. The four

descriptors are:

• Sectors of use (SU)

• Preparation Category (PC)

• Process Category (PROC)

• Article category (AC)

PC: Preparation Category: Element of the use descriptor system characterising the type of

chemical product in which the substance is (finally) used. Includes also intermediates and single

substances marketed as chemical products.

PROC: PROcess Category: Element of the use descriptor system describing the type of technical

processes applied during manufacturing and use (PROCs).

SU: Sectors of Use: Element of the use descriptor system describing the sector of economy

(industry, professional service, private) a substance is used in, as such or in a preparation.

AC: Article Categories: Element of the use descriptor system characterising the type of article in

which a substance is contained.

WMM: Waste Management Measures

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7. ANNEXES

Annexe 1: Model of declaration of honour with respect to the Exclusion Criteria and absence of

conflict of interest

Annex 2: Templates for summary of CV and project descriptions

Annex 3: Powers of attorney

Annex 4: Subcontractor / Letter of Intent

Annex 5: Draft framework service contract

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ANNEX 1: MODEL OF DECLARATION OF HONOUR WITH RESPECT TO THE EXCLUSION CRITERIA

AND ABSENCE OF CONFLICT OF INTEREST

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[Model]

Declaration of honour

with respect to

the Exclusion Criteria and absence of conflict of interest

The undersigned [name of the signatory of this form, to be completed]:

in his/her own name (if the economic operator is a natural person or in case of own

declaration of a director or person with powers of representation, decision making or

control over the economic operator 13 )

or

representing (if the economic operator is a legal person)

official name in full (only for legal person):

official legal form (only for legal person):

official address in full:

VAT registration number:

declares that the company or organisation that he/she represents / he/she:

a) is not bankrupt or being wound up, is not having its affairs administered by the courts, has not

entered into an arrangement with creditors, has not suspended business activities, is not the

13 To be used depending on the national legislation of the country in which the candidate or tenderer is established and

where considered necessary by the contracting authority (see art. 134(4) of the Implementing Rules).

52


subject of proceedings concerning those matters, and is not in any analogous situation arising

from a similar procedure provided for in national legislation or regulations;

b) has not been convicted of an offence concerning professional conduct by a judgment which has

the force of res judicata;

c) has not been guilty of grave professional misconduct proven by any means which the contracting

authorities can justify;

d) has fulfilled all its obligations relating to the payment of social security contributions and the

payment of taxes in accordance with the legal provisions of the country in which it is

established, with those of the country of the contracting authority and those of the country where

the contract is to be carried out;

e) has not been the subject of a judgement which has the force of res judicata for fraud, corruption,

involvement in a criminal organisation or any other illegal activity detrimental to the

Communities’ financial interests;

f) is not a subject of the administrative penalty for being guilty of misrepresentation in supplying

the information required by the contracting authority as a condition of participation in the

procurement procedure or failing to supply an information, or being declared to be in serious

breach of his obligation under contract covered by the budget.

In addition, the undersigned declares on their honour:

g) they have no conflict of interest in connection with the contract; a conflict of interest could arise

in particular as a result of economic interests, political or national affinities, family or emotional

ties or any other relevant connection or shared interest;

h) they will inform the contracting authority, without delay, of any situation considered a conflict of

interest or which could give rise to a conflict of interest;

i) they have not made and will not make any offer of any type whatsoever from which an advantage

can be derived under the contract;

j) they have not granted and will not grant, have not sought and will not seek, have not attempted

and will not attempt to obtain, and have not accepted and will not accept any advantage, financial

or in kind, to or from any party whatsoever, constituting an illegal practice or involving

corruption, either directly or indirectly, as an incentive or reward relating to award of the

contract.

k) that the information provided to the Agency within the context of this invitation to tender is

accurate, sincere and complete.

l) that in case of award of contract, they shall provide the evidence that they are not in any of the

situations described in points a, b, d, e above 14 .

14 Mandatory for contracts of value above €133 000 only (see art. 134(2) of the Implementing Rules). The contracting

authority can nevertheless request such evidence for contracts with a lower value.

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For situations described in (a), (b) and (e), production of a recent extract from the judicial record is required or,

failing that, a recent equivalent document issued by a judicial or administrative authority in the country of origin or

provenance showing that those requirements are satisfied. Where the Tenderer is a legal person and the national

legislation of the country in which the Tenderer is established does not allow the provision of such documents for

legal persons, the documents should be provided for natural persons, such as the company directors or any person

with powers of representation, decision making or control in relation to the Tenderer.

For the situation described in point (d) above, recent certificates or letters issued by the competent authorities of the

State concerned are required. These documents must provide evidence covering all taxes and social security

contributions for which the Tenderer is liable, including for example, VAT, income tax (natural persons only),

company tax (legal persons only) and social security contributions.

For any of the situations (a), (b), (d) or (e), where any document described in two paragraphs above is not issued in

the country concerned, it may be replaced by a sworn or, failing that, a solemn statement made by the interested

party before a judicial or administrative authority, a notary or a qualified professional body in his country of origin or

provenance.]

By signing this form, the undersigned acknowledges that they have been acquainted with the

administrative and financial penalties described under art 133 and 134 b of the Implementing Rules

(Commission Regulation 2342/2002 of 23/12/02), which may be applied if any of the declarations or

information provided prove to be false.

Full name

Signature

Date

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ANNEX 2: TEMPLATES FOR SUMMARY OF CV AND PROJECT DESCRIPTIONS

The following templates are given for reporting:

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- summary of CV

- description of similar services

as requested in section 4.2.1

Summary table of the CV

Member of staff and

position

Project reference form

Educational

Qualifications

Professional

Qualifications

Years of

experience

Summary of Relevant

Experience 1

The Project Reference Form must be used to give details about relevant projects the tenderer wants

to present as proof of experience.

The Project Reference Form consists of two pages:

o Front page

o Description page

Both pages must be used to form a complete Project Reference Form

A new Project Reference Form must be completed for each project.

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Project reference front page

Project title:

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Project Reference Form (page 1 of 2)

Project reference n°____________

Start date (mm/yy): Finish date (mm/yy):

Total Amount (€): Part executed by tenderer:

Client name: Contact person: Phone:

Project type (development, maintenance, etc.):

Principal contractor for this project (tenderer, other, describe as appropriate):

Principal location for this project (tenderer premises, client premises, other):

Number of tenderer’s own technical staff involved in man-days, by profile

1.

2.

3.

4.


Total:

Methodologies involved:

Relevance to the tender:

56


Project description page

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Project Reference Form (page 2 of 2)

Project reference n°____________

57


ANNEX 3: POWERS OF ATTORNEY

POWER OF ATTORNEY – MODEL 1

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Agreement / Power of Attorney

(DESIGNATING ONE OF THE COMPANIES OF THE GROUP AS LEADER AND

We the undersigned:

GIVING A MANDATE TO IT)

– Signatory 1 (Name, Function, Company, Registered address, VAT Number)

– Signatory 2 (Name, Function, Company, Registered address, VAT Number)

– …..

– Signatory N (Name, Function, Company, Registered address, VAT Number),

Each of them having the legal capacity required to act on behalf of his/her company, HEREBY

AGREE AS FOLLOWS:

(1) In case the Agency awards Contract …. (« the Contract ») to Company 1, Company 2, …,

Company N (« the Group Members »), based on the joint offer submitted by them on … ….. for

the supply of ….. and/or the provision of services for … (« the Supplies and/or the Services »).

(2) As co-signatories of the Contract, all the Group Members:

(a) Shall be jointly and severally liable towards the Agency for the performance of the

Contract.

58


(b) Shall comply with the terms and conditions of the Contract and ensure the proper execution

of their respective share of the Supplies and/or the Services.

(3) To this effect, the Group Members designate Company X as Group Leader. [N.B.: The

Group Leader has to be one of the Group Members]

(4) Payments by the Agency related to the Supplies or the Services shall be made through the

Group Leader’s bank account .[Provide details on bank, address, account number, etc.].

(5) The Group Members grant to the Group Leader all the necessary powers to act on their

behalf in connection with the Supplies and/or the Services. This mandate involves in

particular the following tasks:

(a) The Group Leader shall sign any contractual documents —including the Contract, and

Amendments thereto— and issue any invoices related to the Supplies or the Services on

behalf of the Group Members.

(b) The Group Leader shall act as single point of contact for the Agency in connection with the

Supplies and/or the Services to be provided under the Contract. It shall co-ordinate the

provision of the Supplies and/or the Services by the Group Members to the Agency, and

shall see to a proper administration of the Contract.

Any modification to the present agreement / power of attorney shall be subject to the Agency’s

express approval.

This agreement / power of attorney shall expire when all the contractual obligations of the Group

Members towards the Agency in connection with the Supplies and/or the Services to be provided

under the Contract have ceased to exist. The parties cannot terminate it before that date without the

Agency’s consent.

Signed in ………… on ……….. ………

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Name

Function

Company

Name

Function

Company

Name

Function

Company

Name

Function

Company

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POWER OF ATTORNEY – MODEL 2

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Agreement / Power of Attorney

(CREATING THE GROUP AS SEPARATE ENTITY, APPOINTING A GROUP

We the undersigned:

MANAGER AND GIVING A MANDATE TO HIM/HER)

– Signatory 1 (Name, Function, Company, Registered address, VAT Number)

– Signatory 2 (Name, Function, Company, Registered address, VAT Number)

– …..

– Signatory N (Name, Function, Company, Registered address, VAT Number),

Each of them having the legal capacity required to act on behalf of his/her company, HEREBY

AGREE AS FOLLOWS:

(1) In case the Agency awards Contract …. (« the Contract ») to Company 1, Company 2, …,

Company N (« the Group Members »), based on the joint offer submitted by them on … ….. for

the supply of ….. and/or the provision of services for … (« the Supplies and/or the Services »).

(2) As co-signatories of the Contract, all the Group Members:

(a) Shall be jointly and severally liable towards the Agency for the performance of the

Contract.

(b) Shall comply with the terms and conditions of the Contract and ensure the proper execution

of their respective share of the Supplies and/or the Services.

61


(3) To this effect, the Group Members have set up under the laws of ……. the Group ….. (« the

Group »). The Group has the legal form of a .….. [Provide details on registration of the Group:

VAT Number, Trade Register, etc.].

(4) Payments by the Agency related to the Supplies or the Services shall be made through the

Group’s bank account . [Provide details on bank, address, account number, etc.].

(5) The Group Members appoint Mr/Ms ……. as Group Manager.

(6) The Group Members grant to the Group Manager all the necessary powers to act alone on their

behalf in connection with the Supplies and/or the Services. This mandate involves in particular the

following tasks :

(a) The Group Manager shall sign any contractual documents – including the Contract and

Amendments thereto – and issue any invoices related to the Supplies or the Services on

behalf of the Group Members.

(b) The Group Manager shall act as single point of contact for the Agency in connection with

the Supplies and/or the Services to be provided under the Contract. He/she shall co-ordinate

the provision of the Supplies and/or the Services by the Group Members to the Agency, and

shall see to a proper administration of the Contract.

Any modification to the present agreement / power of attorney shall be subject to the

Agency’s express approval.

This agreement / power of attorney shall expire when all the contractual obligations of the Group

Members towards the Agency in connection with the Supplies and/or the Services to be provided

under the Contract have ceased to exist. The parties cannot terminate it before that date without the

Agency’s consent.

Signed in ……... on ……….. ………

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Name

Function

Company

Name

Function

Company

Name

Function

Company

Name

Function

Company

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ANNEX 4: LETTER OF INTENT SUBCONTRACTOR

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FRAMEWORK CONTRACT -ECHA/2008/24

Development of a Chemical Safety Assessment tool

The undersigned: ………………………………………………………………………….

Name of the company/organisation: ………………………………………………………

Address: ……………………………………………………………………………………

Declares hereby the intention to collaborate in the execution of the tasks subject to the above

call for tender, in accordance with the terms of the offer to which the present form is annexed, if

the contract is awarded to … …. [name of the tenderer].

Declares hereby accepting the general conditions attached to the tendering specifications for

this call for tender, and in particular art. II.17 in relation with checks and audits.

Full name Date

Signature

............................................................................................................................................

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ANNEX 5: DRAFT FRAMEWORK SERVICE CONTRACT

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