# C_2011366EN.01003301.xml

| 15.12.2011 | EN | Official Journal of the European Union | C 366/33 |
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15.12.2011

EN

Official Journal of the European Union

C 366/33

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REPORT

on the annual accounts of the European Chemicals Agency for the financial year 2010, together with the Agency’s reply

2011/C 366/07

INTRODUCTION

INTRODUCTION

| 1. | The European Chemicals Agency (hereinafter referred to as ‘the Agency’), which is located in Helsinki, was set up by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 (1). Its main tasks are to ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. The Agency also promotes the development of alternative methods for the assessment of hazards relating to substances (2). The Agency became financially independent of the Commission on 1 January 2008. |
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1.

The European Chemicals Agency (hereinafter referred to as ‘the Agency’), which is located in Helsinki, was set up by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 (1). Its main tasks are to ensure a high level of protection of human health and the environment as well as the free movement of substances, on their own, in preparations and in articles, while enhancing competitiveness and innovation. The Agency also promotes the development of alternative methods for the assessment of hazards relating to substances (2). The Agency became financially independent of the Commission on 1 January 2008.

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| 2. | The Agency’s 2010 budget amounted to 75 million euro, compared with 70,4 million euro the previous year. The number of staff employed by the Agency at the end of the year was 472, compared with 355 the previous year. |
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2.

The Agency’s 2010 budget amounted to 75 million euro, compared with 70,4 million euro the previous year. The number of staff employed by the Agency at the end of the year was 472, compared with 355 the previous year.

STATEMENT OF ASSURANCE

STATEMENT OF ASSURANCE

| 3. | Pursuant to the provisions of Article 287(1), second subparagraph, of the Treaty on the Functioning of the European Union, the Court has audited the annual accounts (3) of the Agency, which comprise the ‘financial statements’ (4) and the ‘reports on the implementation of the budget’ (5) for the financial year ended 31 December 2010, and the legality and regularity of the transactions underlying those accounts. |
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3.

Pursuant to the provisions of Article 287(1), second subparagraph, of the Treaty on the Functioning of the European Union, the Court has audited the annual accounts (3) of the Agency, which comprise the ‘financial statements’ (4) and the ‘reports on the implementation of the budget’ (5) for the financial year ended 31 December 2010, and the legality and regularity of the transactions underlying those accounts.

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| 4. | This Statement of Assurance is addressed to the European Parliament and the Council in accordance with Article 185(2) of Council Regulation (EC, Euratom) No 1605/2002 (6). |
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4.

This Statement of Assurance is addressed to the European Parliament and the Council in accordance with Article 185(2) of Council Regulation (EC, Euratom) No 1605/2002 (6).

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The Director’s responsibility

The Director’s responsibility

| 5. | As authorising officer, the Director implements the revenue and expenditure of the budget in accordance with the financial rules of the Agency, under his own responsibility and within the limits of the authorised appropriations (7). The Director is responsible for putting in place (8) the organisational structure and the internal management and control systems and procedures relevant for drawing up final accounts (9) that are free from material misstatement, whether due to fraud or error, and for ensuring that the transactions underlying those accounts are legal and regular. |
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5.

As authorising officer, the Director implements the revenue and expenditure of the budget in accordance with the financial rules of the Agency, under his own responsibility and within the limits of the authorised appropriations (7). The Director is responsible for putting in place (8) the organisational structure and the internal management and control systems and procedures relevant for drawing up final accounts (9) that are free from material misstatement, whether due to fraud or error, and for ensuring that the transactions underlying those accounts are legal and regular.

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The Court’s responsibility

The Court’s responsibility

| 6. | The Court’s responsibility is to provide, on the basis of its audit, a statement of assurance as to the reliability of the annual accounts of the Agency and the legality and regularity of the transactions underlying them. |
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6.

The Court’s responsibility is to provide, on the basis of its audit, a statement of assurance as to the reliability of the annual accounts of the Agency and the legality and regularity of the transactions underlying them.

| 7. | The Court conducted its audit in accordance with the IFAC and ISSAI (10) International Auditing Standards and Codes of Ethics. Those standards require the Court to comply with ethical requirements and to plan and perform the audit so as to obtain reasonable assurance as to whether the accounts are free of material misstatement and whether the underlying transactions are legal and regular. |
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7.

The Court conducted its audit in accordance with the IFAC and ISSAI (10) International Auditing Standards and Codes of Ethics. Those standards require the Court to comply with ethical requirements and to plan and perform the audit so as to obtain reasonable assurance as to whether the accounts are free of material misstatement and whether the underlying transactions are legal and regular.

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| 8. | The Court’s audit involves performing procedures to obtain audit evidence of the amounts and disclosures in the accounts and of the legality and regularity of the transactions underlying them. The procedures selected, including its assessment of the risks of material misstatement of the accounts or of illegal or irregular transactions, whether due to fraud or error, depend on its audit judgement. In making those risk assessments, internal controls relevant to the entity’s preparation and presentation of accounts are considered in order to design audit procedures that are appropriate in the circumstances. The Court’s audit also includes evaluating the appropriateness of the accounting policies used and the reasonableness of the accounting estimates made by management, as well as evaluating the overall presentation of the accounts. |
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8.

The Court’s audit involves performing procedures to obtain audit evidence of the amounts and disclosures in the accounts and of the legality and regularity of the transactions underlying them. The procedures selected, including its assessment of the risks of material misstatement of the accounts or of illegal or irregular transactions, whether due to fraud or error, depend on its audit judgement. In making those risk assessments, internal controls relevant to the entity’s preparation and presentation of accounts are considered in order to design audit procedures that are appropriate in the circumstances. The Court’s audit also includes evaluating the appropriateness of the accounting policies used and the reasonableness of the accounting estimates made by management, as well as evaluating the overall presentation of the accounts.

| 9. | The Court believes that the audit evidence obtained is sufficient and appropriate to provide a basis for the opinions set out below. |
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9.

The Court believes that the audit evidence obtained is sufficient and appropriate to provide a basis for the opinions set out below.

Opinion on the reliability of the accounts

Opinion on the reliability of the accounts

| 10. | In the Court’s opinion, the Agency’s Annual Accounts (11) fairly present, in all material respects, its financial position as of 31 December 2010 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation. |
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10.

In the Court’s opinion, the Agency’s Annual Accounts (11) fairly present, in all material respects, its financial position as of 31 December 2010 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation.

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Opinion on the legality and the regularity of the transactions underlying the accounts

Opinion on the legality and the regularity of the transactions underlying the accounts

| 11. | In the Court’s opinion, the transactions underlying the annual accounts of the Agency for the financial year ended 31 December 2010 are, in all material respects, legal and regular. |
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11.

In the Court’s opinion, the transactions underlying the annual accounts of the Agency for the financial year ended 31 December 2010 are, in all material respects, legal and regular.

| 12. | The comments which follow do not call the Court’s opinions into question. |
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12.

The comments which follow do not call the Court’s opinions into question.

COMMENTS ON THE BUDGETARY AND FINANCIAL MANAGEMENT

COMMENTS ON THE BUDGETARY AND FINANCIAL MANAGEMENT

| 13. | In 2010, the Agency became fully self-financing. There is scope for the Agency’s Financial Regulation to be revised to include a mechanism for retaining surplus own revenue to finance the Agency’s future activities. |
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13.

In 2010, the Agency became fully self-financing. There is scope for the Agency’s Financial Regulation to be revised to include a mechanism for retaining surplus own revenue to finance the Agency’s future activities.

This Report was adopted by Chamber IV, headed by Mr Igors LUDBORŽS, Member of the Court of Auditors, in Luxembourg at its meeting of 6 September 2011.

For the Court of Auditors

Vítor Manuel da SILVA CALDEIRA

President

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(1)  OJ L 396, 30.12.2006, p. 1.

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(2)  The Annex summarises the Agency's competences and activities. It is presented for information purposes.

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Annex

(3)  These accounts are accompanied by a report on the budgetary and financial management during the year which gives inter alia an account of the rate of implementation of the appropriations, with summary information on the transfers of appropriations among the various budget items.

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(4)  The financial statements include the balance sheet and the economic outturn account, the cash-flow table, the statement of changes in capital and the annex to the financial statements, which includes a description of the main accounting policies and other explanatory information.

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(5)  The budget implementation reports comprise the budget outturn account and its annex.

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(6)  OJ L 248, 16.9.2002, p. 1.

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(7)  Article 33 of Commission Regulation (EC, Euratom) No 2343/2002 (OJ L 357, 31.12.2002, p. 72).

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(8)  Article 38 of Regulation (EC, Euratom) No 2343/2002.

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(9)  The rules concerning the presentation of the accounts and accounting by the Agencies are laid down in Chapter 1 of Title VII of Regulation (EC, Euratom) No 2343/2002 as last amended by Regulation (EC, Euratom) No 652/2008 (OJ L 181, 10.7.2008, p. 23) and are integrated as such in the Financial Regulation of the Agency.

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(10)  International Federation of Accountants (IFAC) and International Standards of Supreme Audit Institutions (ISSAI).

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(11)  The Final Annual Accounts were drawn up on 23 June 2011 and received by the Court on 29 June 2011. The Final Annual Accounts can be found on the following website http://eca.europa.eu or http://echa.europa.eu/publications/annual_accounts_en.asp

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ANNEX

European Chemicals Agency (Helsinki)

Competences and activities

| Areas of Union competence deriving from the Treaty | The legal base of ECHA's founding regulation, the REACH Regulation (EC) No 1907/2006, is Article 114 of the Treaty on the Functioning of the European Union. |
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| Competences of the Agency


  (Regulations (EC) No 1907/2006 (REACH Regulation) and (EC) No 1272/2008) | Objectives

  The purpose of the REACH Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards relating to substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation (Article 1 of the REACH Regulation).
  The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication concerning this Regulation and in its implementation. The confidence of the Union institutions, the Member States, the general public and interested parties in the Agency is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency (recital 95 of the REACH Regulation).

  Tasks

  ECHA is established for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of the REACH Regulation and to ensure consistency at Union level in relation to these aspects (Article 75 of the REACH Regulation).
  The Agency is also to provide the Member States and the institutions of the Union with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of the REACH Regulation (Article 77(1) of the REACH Regulation).
  ECHA also has tasks related to the classification and labelling of chemical substances deriving from the CLP Regulation (EC) 1272/2008. In particular, the Agency is to provide Member States and the institutions of the Union with the best possible scientific advice and provide industry and Member State authorities with technical and scientific guidance. |
| Governance | 1 —   Management Board

  One representative of each Member State, appointed by the Council, and a maximum of six representatives appointed by the Commission, including three individuals from interested parties without voting rights and, in addition, two independent persons appointed by the European Parliament. (Article 79 of the REACH Regulation).
  Tasks: Article 78 of the REACH Regulation and framework financial regulation for agencies, mainly adopting annual and multi-annual work programme, the final budget, a general report, internal rules of procedures and appointment of and disciplinary authority over of the Executive Director. In addition appointment of Board of Appeal and Committee members.

  2 —   Executive Director

  Tasks: Article 83 of the REACH Regulation.

  3 —   Committees

  ECHA comprises three Committees (Risk Assessment, Member States and Socio-Economic Analysis).
  Tasks: Article 76(1)(c-e) of the REACH Regulation.

  4 —   Forum for Exchange of Information on Enforcement

  Tasks: Article 76(1)(f) of the REACH Regulation.

  5 —   Secretariat

  Tasks: Article 76(1)(g) of the REACH Regulation.

  6 —   Board of Appeal

  Tasks: Article 76(1)(h) of the REACH Regulation.

  7 —   External audit

  Court of Auditors.

  8 —   Discharge authority

  Parliament, acting on a recommendation from the Council. |
| Resources made available to the Agency in 2010 (2009) | Budget (including amending budgets)

  75,5 (70,4) million euro, including revenue from fees: 35,0 (2,2) million euro and Union contribution: 36,0 (66,6) million.

  Staff at 31 December 2010

  426 (324) posts in the establishment plan.
  Number of posts occupied: 382 (293).
  Other staff: 90 (62)

  contract agents, seconded national experts and interims.

  Total staff: 472 (355)

  Assigned to the following duties:






  — | operational tasks: 341 (237), |

Areas of Union competence deriving from the Treaty

The legal base of ECHA's founding regulation, the REACH Regulation (EC) No 1907/2006, is Article 114 of the Treaty on the Functioning of the European Union.

Competences of the Agency

(Regulations (EC) No 1907/2006 (REACH Regulation) and (EC) No 1272/2008)

Objectives

The purpose of the REACH Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards relating to substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation (Article 1 of the REACH Regulation).

The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication concerning this Regulation and in its implementation. The confidence of the Union institutions, the Member States, the general public and interested parties in the Agency is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency (recital 95 of the REACH Regulation).

Tasks

ECHA is established for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of the REACH Regulation and to ensure consistency at Union level in relation to these aspects (Article 75 of the REACH Regulation).

The Agency is also to provide the Member States and the institutions of the Union with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of the REACH Regulation (Article 77(1) of the REACH Regulation).

ECHA also has tasks related to the classification and labelling of chemical substances deriving from the CLP Regulation (EC) 1272/2008. In particular, the Agency is to provide Member States and the institutions of the Union with the best possible scientific advice and provide industry and Member State authorities with technical and scientific guidance.

Governance

1 —   Management Board

One representative of each Member State, appointed by the Council, and a maximum of six representatives appointed by the Commission, including three individuals from interested parties without voting rights and, in addition, two independent persons appointed by the European Parliament. (Article 79 of the REACH Regulation).

Tasks: Article 78 of the REACH Regulation and framework financial regulation for agencies, mainly adopting annual and multi-annual work programme, the final budget, a general report, internal rules of procedures and appointment of and disciplinary authority over of the Executive Director. In addition appointment of Board of Appeal and Committee members.

2 —   Executive Director

Tasks: Article 83 of the REACH Regulation.

3 —   Committees

ECHA comprises three Committees (Risk Assessment, Member States and Socio-Economic Analysis).

Tasks: Article 76(1)(c-e) of the REACH Regulation.

4 —   Forum for Exchange of Information on Enforcement

Tasks: Article 76(1)(f) of the REACH Regulation.

5 —   Secretariat

Tasks: Article 76(1)(g) of the REACH Regulation.

6 —   Board of Appeal

Tasks: Article 76(1)(h) of the REACH Regulation.

7 —   External audit

Court of Auditors.

8 —   Discharge authority

Parliament, acting on a recommendation from the Council.

Resources made available to the Agency in 2010 (2009)

Budget (including amending budgets)

75,5 (70,4) million euro, including revenue from fees: 35,0 (2,2) million euro and Union contribution: 36,0 (66,6) million.

Staff at 31 December 2010

426 (324) posts in the establishment plan.

Number of posts occupied: 382 (293).

Other staff: 90 (62)

contract agents, seconded national experts and interims.

Total staff: 472 (355)

Assigned to the following duties:

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operational tasks: 341 (237),

| — | administrative and support tasks: 131 (118). |
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administrative and support tasks: 131 (118).

Activities and services provided in 2010 (2009)

   (1)

ECHA's Work Programme was divided into the following 11 Activities:

1.   Registration, Pre-registration and Data-sharing

| — | Preparation for and handling of submissions under the first REACH registration deadline. |
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Preparation for and handling of submissions under the first REACH registration deadline.

| — | Number of completed registration dossiers exc. PPORDs: 25 000(500). |
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Number of completed registration dossiers exc. PPORDs: 25 000(500).

| — | Number of inquiries: 1 600(1 000). |
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Number of inquiries: 1 600(1 000).

| — | Number of decisions issued on data sharing disputes: 9 (0). |
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Number of decisions issued on data sharing disputes: 9 (0).

2.   Evaluation

| — | Capacity building. |
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Capacity building.

| — | Number of compliance checks completed: 70 (14). |
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Number of compliance checks completed: 70 (14).

| — | Number of final decisions on testing proposals: 4 (1). |
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Number of final decisions on testing proposals: 4 (1).

3.   Authorisation and restrictions

| — | Number of substances identified for inclusion in the Candidate list: 16 (15). |
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Number of substances identified for inclusion in the Candidate list: 16 (15).

| — | Number of recommendations of substances for inclusion as priority substances in REACH Annex XIV: 1 (1). |
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Number of recommendations of substances for inclusion as priority substances in REACH Annex XIV: 1 (1).

| — | Number of restriction dossiers prepared: 1 (0). |
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Number of restriction dossiers prepared: 1 (0).

| — | Number of finalised review reports on substances contained in REACH Annex XVII: 6 (0). |
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Number of finalised review reports on substances contained in REACH Annex XVII: 6 (0).

| — | Capacity building. |
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Capacity building.

4.   Classification and Labelling (C&L)

| — | Preparation for and handling of submissions for C&L notifications deadline. |
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Preparation for and handling of submissions for C&L notifications deadline.

| — | Number of C&L notifications received: over 3 million for over 100 000 substances. |
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Number of C&L notifications received: over 3 million for over 100 000 substances.

| — | Number of proposals for harmonised classification and labelling received: 81 (33). |
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Number of proposals for harmonised classification and labelling received: 81 (33).

5.   Advice and assistance

| — | Helpdesk and guidance support to industry, in anticipation of regulatory deadlines. |
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Helpdesk and guidance support to industry, in anticipation of regulatory deadlines.

| — | Number of questions answered by helpdesk: 10 000(6 600). |
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Number of questions answered by helpdesk: 10 000(6 600).

| — | Number of new guidance documents issued: 2 (2). |
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Number of new guidance documents issued: 2 (2).

| — | Number of guidance updates issued: 12 (0). |
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Number of guidance updates issued: 12 (0).

6.   IT Support to operations

| — | Further development of REACH-IT and other scientific IT systems. |
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Further development of REACH-IT and other scientific IT systems.

7.   Scientific and Practical Advice for the further development of legislation

| — | At the request of the European Commission, contributions on nanomaterials and to OECD programme on test guidelines and to the proposal on Biocides Regulation. |
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At the request of the European Commission, contributions on nanomaterials and to OECD programme on test guidelines and to the proposal on Biocides Regulation.

8.   Committees and Forum

| — | Number of unanimous MSC agreements: 26 (15). |
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Number of unanimous MSC agreements: 26 (15).

| — | Number of RAC opinions: 16 (1). |
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Number of RAC opinions: 16 (1).

9.   Board of Appeal

| — | Decisions on procedural rules adopted. |
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Decisions on procedural rules adopted.

10.   Communication

| — | 2 Stakeholder days with 700 participants. |
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2 Stakeholder days with 700 participants.

| — | 3 000 participants in lead registrant webinars. |
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3 000 participants in lead registrant webinars.

| — | Over 60 publications. |
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Over 60 publications.

| — | 2 300 pages translated into EU 21 languages. |
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2 300 pages translated into EU 21 languages.

| — | 2,5 million website visits from 200 countries. |
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2,5 million website visits from 200 countries.

11.   Relations with EU Institutions and International Cooperation

| — | Memorandum of Understanding with Canada signed. |
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Memorandum of Understanding with Canada signed.

| — | Statement of intent with US Environmental Protection Agency signed. |
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Statement of intent with US Environmental Protection Agency signed.

| — | Scientific and technical cooperation with OECD. |
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Scientific and technical cooperation with OECD.

Source: Information supplied by the Agency.

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(1)  Where appropriate, figures have been rounded up/down to the nearest 10, 100, or 1000.

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THE AGENCY’S REPLY

| 13. | The Agency will include a proposal for mechanism to manage surplus revenue in the upcoming review of the Framework Financial Regulation. |
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13.

The Agency will include a proposal for mechanism to manage surplus revenue in the upcoming review of the Framework Financial Regulation.

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