Areas of Union competence deriving from the Treaty Collection of information — 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 (as defined in Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH Regulation), Regulation (EC) No 1272/2008 of the European Parliament and of the Council (Classification, labelling and packaging of substances and mixtures), Regulation (EU) No 528/2012 of the European Parliament and of the Council (Biocidal Products Regulation) and Regulation (EU)No 649/2012 of the European Parliament and of the Council (Prior informed consent) Objectives — The purpose of the REACH and CLP Regulations is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for the assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation (Article 1(1) of the REACH Regulation, Article 1 of CLP Regulation). — 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) and to manage tasks related to the classification and labelling of chemical substances deriving from the CLP Regulation. Tasks — To receive registrations and other dossiers of chemical substances and undertake a completeness check thereof (Title II of the REACH Regulation). — To process inquiries regarding the registrations and take decisions on data sharing disputes (Title III of the REACH Regulation). — To examine registration dossiers for compliance with the REACH Regulation and the testing proposals therein, and coordinate the substance evaluation process (Title VI of the REACH Regulation). — To process proposals of substances of very high concern for the Candidate List and make recommendations for some of these substances to be included in the Authorisation List and handle authorisation applications (Title VII of the REACH Regulation). — To process restriction dossiers (Title VIII of the REACH Regulation). — To establish and maintain public database(s) with information on all registered substances and make certain information publicly available over the Internet (Article 77, 119 of the REACH Regulation). — To provide technical and scientific guidance and tools where appropriate (Article 77 of the REACH Regulation, Article 50(2) of CLP Regulation). — To provide the Member States and the EU institutions 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 and CLP Regulations (Article 77(1) of the REACH Regulation, Article 50(1) of CLP Regulation). — To receive C&L notifications, maintain a public C&L inventory, handle requests for alternative names and process proposals for the harmonised classification and labelling of substances (CLP). — To implement technical and scientific tasks in accordance with the Biocidal Products Regulation when it enters into operation. — To implement tasks under the PIC (‘Prior Informed Consent’) Regulation when it enters into operation.

Governance 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 multiannual work programmes, the final budget, a general report, internal rules of procedures and the appointment of and disciplinary authority over the Executive Director. In addition, the appointment of the Board of Appeal and Committee members. Executive Director Tasks Article 83 of the REACH Regulation. Committees The Agency comprises three Scientific Committees (Risk Assessment, Member States and Socio-Economic Analysis). Tasks Article 76(1)(c-e) of the REACH Regulation. Forum for Exchange of Information on Enforcement Tasks Article 76(1)(f) of the REACH Regulation. Secretariat Tasks Article 76(1)(g) of the REACH Regulation. Board of Appeal Tasks Article 76(1)(h) of the REACH Regulation. External audit European Court of Auditors. Internal audit European Commission’s Internal Audit Service (IAS). Discharge authority European Parliament, upon recommendation from the Council (Article 97(10) of REACH Regulation.

Resources made available to the Agency in 2012 (2011) Budget (including amending budgets) — 98,9 (93,2) million euro, including: — Revenue from fees: 26,6 (33,5) million euro; — Union contribution: 4,9 (0,0) million euro to support the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (3,2 million euro), Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (1,5 million euro) and the instrument for pre-accession – IPA (0,2 million euro). Staff at 31 December 2012 — Number of posts in the establishment plan: 470 (456) — Number of posts occupied: 447 (441) — Other staff: 65 (90) (contract staff and seconded national experts) — Total staff: 506 (537), assigned to the following: — Operational tasks: 352 (333); — Administrative and support tasks: 185 (173)

Activities and services provided 2012 (2011) ECHA’s Work Programme was divided into the following 16 Activities: Registration, Pre-registration and Data-sharing — Number of registration dossiers processed: 9 773(6 100) — Number of confidentiality requests assessments completed: 871 (630) [note: 639 (229) confidentiality requests in accordance with Article 119(2)] — Number of inquiries received: 1 632(1 970) — Number of decisions issued on data sharing disputes: 1 (3) — Number of substances on which info made public (excluding confidential info): 7 884(4 100) Evaluation — Number of compliance checks completed: 198 (146) — Number of final decisions on testing proposals: 171 (22) Risk Management — Number of substances identified for inclusion in the Candidate List: 67 (28) — Number of recommendations of substances for inclusion in Authorisation List: 0 (1) — Number of restriction dossiers submitted for Commission decision: 1 (4) — Number of authorisation applications received: 0 (0) — Number of notifications of Candidate List substances in articles: 31 (203) Classification and Labelling (C&L) — Number of C&L notifications received: 5,7 million for over 120 000 substances — Number of proposals for harmonised classification and labelling received: 27 (56) — Number of requests for alternative names for substances in mixtures: 13 (0) Advice and assistance — Number of questions answered by helpdesk: 5 684 — Number of new guidance documents issued: 0 (3) and no. of guidance updates issued: 30 including 17 corrigenda (14) Scientific IT Tools — REACH-IT modifications for the 2013 deadline. — Further enhancement and release of IT Tools: IUCLID, CHESAR, Odyssey. — IT solutions for Member States to access dossier and substance data. — Further enlargement of the scope of the disseminated information on substances. — Release and maintenance of the C&L Inventory. — Development of a C&L platform for collaboration. — Release of IT workflow support for the evaluation processes. Scientific and Technical Advice to EU institutions and bodies — Contract signed to support further development of risk assessment methodologies for ‘complex’ substances. — Computational methods are routinely applied in support of the different processes. — First GAARN (Group Assessing Already Registered Nanomaterials) meeting organised. — Publication of ‘Best Practices on physicochemical and substance identity information for nanomaterials’ and other guidance documents updated. — OECD expert meeting hosted where testing strategy for skin irritants was drafted. — Contributions provided to the development of core genotoxicity test methods provided for in REACH ITS (Integrated Test Strategy) and to the work of PARERE (Preliminary Analysis of Regulatory Relevance). Committees and Forum — Number of unanimous MSC agreements: 179 (2) — Number of RAC opinions: 34 (36) — Number of SEAC opinions: 1 (0) Board of Appeal — Number of appeals lodged: 8 (6) — Number of decisions on appeals:1 (6) and Number of procedural decisions: 6 (10) Communication — 4 Stakeholder events organised: — 1st Lead Registrant Workshop in February (74 + 175 via web-stream), — 2nd Lead Registrant Workshop in October (76 + 200 via web-stream), — 7th Stakeholders’ Day in May (287 external participants + 353 via web-stream), — Accredited Stakeholder Workshop in November (21 participants). — 16 webinars organised with 2 999 participants. — 276 documents translated. — 92 publications. — 39 press releases, 62 news alerts, 6 newsletters. — 3 million website visitors. International Cooperation — Scientific and technical cooperation with OECD (e.g. ChemPortal; QSAR Toolbox). Management — Continued development and improvement of administrative and management systems, including IQMS. Finance, Procurement and Accounting — Rigorous budget and cash reserve management. — High number of procurement actions undertaken, e.g. to establish a new generation of framework contracts for IT services and framework contracts in the areas of scientific services, communication and administrative services. — Total number of companies verified regarding SME status: 315. Human resources and corporate services — 23 (24) selection procedures finalised; 65 (93) staff members recruited (TA and CA). Information and Communication Technology — Provision of services to keep the ICT infrastructure and ICT resources operational and at the appropriate level of performance. — Establishment of a Business Continuity solution for mission-critical IT systems leveraging on the outsourced hosting services. — Deployment of a time recording system. — Migration of all the workstations software to update versions. Biocides — Analysis, design and implementation of the Register for Biocidal Products (R4BP). — First draft key guidance documents developed. — Preliminary work plan for the Biocidal Products Committee. — Member States have been invited to appoint Members, provide the Chair and Secretariat for the new Committee and undertake preparations for the Coordination Group. PIC — Preparatory activities.