The Annexes of REACH

Homepage - ECHA. Defra - Department for Environment, Food and Rural Affairs. REACH LEGISLATION ANNEXES - REACH Compliance - Review of annexes - Chemicals - Enterprise and Industry. Reviews have been made or are currently ongoing of the following Annexes: Annex I, Annex II, Annex IV, Annex V, Annex XI, Annex XIII, Annex XVII Stakeholder consultation The Commission engaged Member States and other stakeholders on the reviews, in most cases in a sub-group of the REACH Competent Authorities (CA); the Competent Authority Sub Group for the review of the Annexes of REACH (CASG (Annexes)).

Annex I Annex I of Regulation (EC) No. 1907/2006 (REACH) sets out the details of how to carry out a Chemical Safety Assessment and document it in a Chemical Safety Report. The Annex has been supplemented by a technical guidance document on Information Requirements and Chemical Safety Assessment. Article 138(4) mandated the Commission to carry out a review of Annex I of REACH by 1 June 2008, with a view to proposing amendments, if appropriate. The Commission has however adopted a Regulation. REACH Definitions & REACH Acronyms. ANNEX I : GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS.

ANNEX II : GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS. ANNEX III : CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES. ANNEX IV: Exemptions from the obligation to register in accordance with article 2(7)(a) - EINECS: European INventory of Existing Commercial chemical Substances - -REACH Compliance - ANNEX V. IN ACCORDANCE WITH ARTICLE 2(7)(b) 1.

Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight. 2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article. 3. 4. (a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or (b) a substance solely intended to provide a specific physicochemical characteristic functions as intended. 5. 6. 1. 2. 3.

GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI. ANNEX VII : STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE. ANNEX VIII : STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE. ANNEX IX : STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE. ANNEX X : STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE. ANNEX XI : GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X. [annexXI] REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals. Annexes VII to X set out the information requirements for all substances manufactured or imported in quantities of: - one tonne or more in accordance with Article 12(1)(a), - 10 tonnes or more in accordance with Article 12(1)(c), - 100 tonnes or more in accordance with Article 12(1)(d), and - 1000 tonnes or more in accordance with Article 12(1)(e).

In addition to the specific rules set out in column 2 of Annexes VII to X, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. 1.1. 1.1.1. Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met: (1) adequacy for the purpose of classification and labelling and/or risk assessment; (2) sufficient documentation is provided to assess the adequacy of the study; and 1.1.2. . (4) adequate and reliable documentation of the study is provided. 1.1.3. 1.2. 1.3. 1.5. 3.1. 3.2.

ANNEX XII : GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS. ANNEX XIII : CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES. ANNEX XIV : LIST OF SUBSTANCES SUBJECT TO AUTHORISATION. ANNEX XV : DOSSIERS. ANNEX XVI : SOCIO-ECONOMIC ANALYSIS.

ANNEX XVII : RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES. Commission Review of REACH Annexes - Environment. Additional tools.

Preparing for REACH - Environment. Additional tools To enable a smooth transition from the existing chemicals legislation to REACH, the Commission has developed within an interim strategy a number of REACH Implementation Projects (RIPs) to ensure that all stakeholders, especially industry and public authorities, are adequately prepared for the practical application of the new system.

These Implementation Projects foresee the development of guidance documents and IT-tools for the European Chemicals Agency, for industry and the authorities of the Member States including 5 central areas: The European Chemicals Bureau (ECB) in Ispra has been given the responsibility to develop those tools and methodologies as it has the main practical experience from administering the practical implementation of the pre-REACH chemicals legislation, while DG ENV and DG ENTR ensure the political and legislative compatibility. The activities are coordinated closely with the main stakeholders i.e. Member States, Industry and NGOs. REACH Enforcement - Environment. Additional tools Under REACH (Art 126) the Member States authorities are responsible for the enforcement of the REACH provisions.

In other words, each Member State must determine inter alia the penalties that would apply to the infringement of REACH provisions and must take all measures necessary to ensure that they are implemented. The penalties must be "effective, proportionate and dissuasive". The Member States had to notify their provisions to the European Commission and must also notify any subsequent amendment. Commission Review of REACH Annexes - Environment. Additional tools The Commission has the possibility to review and amend Annexes of REACH in line with Article 131.

Several reviews were specifically mandated by Article 138 or other provisions in REACH. REACH: Legislation. REACH legal text The original REACH legal text has been amended on a number of occasions since its original publication.

The amendments made until July 2013 are listed below. The latest consolidated version of REACH together with related Legislation & Case Law is available on the legislation page on website of the European Chemicals Agency Please note that the legislation has been amended on a number of occasions since its original publication. The amendments made until the end of February 2012 are listed below. Factsheet.pdf (application/pdf Object) Inbrief.pdf (application/pdf Object) Qa.pdf (application/pdf Object)