The purpose of this regulation is to ensure a high level of protection of human health and the environment. It shall apply without prejudice to Community workplace and environmental legislation. There are exemptions on medical, veterinary, alimentary and cosmetic products, polymers and some on-site isolated intermediates.
The following terms are defined: substance, mixture, article, producer of an article, polymer, monomer, registrant, manufacturing, manufacturer, import, importer, placing on the market, downstream user, distributor, intermediate, site, actors in supply chain, Agency, competent authority, phase-in substance, notified substance, product and process orientated research and development, scientific research and development, use, registrant's own use, full study report, robust study summary, study summary, per year, restriction, supplier and recipient of a substance / mixture / article, SME, exposure scenario, use and exposure category, substances which occur in nature, not chemically modified substance, alloy.
Substances that are subject to this regulation, on their own, in mixtures or in articles:
- in quantities of one tonne or more per year;
- intended to be released under normal or reasonably foreseeable conditions of use,
shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions where this is required.
Save where this Regulation provides otherwise, any manufacturer or importer of a substance shall submit a registration to the European Chemicals Agency in Helsinki. The regulation details the duties of the Agency, the procedure of registration and the sharing of existing knowledge.
There are exemptions from the general obligation to register for product and process orientated research and development.
Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. A chemical safety assessment of a substance shall include the following steps:
- human health hazard assessment
- physicochemical hazard assessment
- environmental hazard assessment
- persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
If a substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB, the chemical safety assessment shall include additional steps.
Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies.
Certain plant protection substances and biocidal products on which information was previously compiled need not be re-registered. Registration of on-site and transported isolated intermediates may require less data, if certain provisions are fulfilled.
The supplier of a substance or a mixture shall provide the recipient of the substance or ation with a safety data sheet (SDS) compiled in accordance with Annex II:
- for substances classified as dangerous or
- for PBT or vPvB or
- for substances on the candidate list compiled by the Agency.
The supplier shall provide the recipient at his request with a safety data sheet where a ation does not meet the criteria for classification as dangerous, but contains substance(s) in a given concentrations:
- posing human health or environmental hazards or
- PBT or vPvB or
- included in the candidate list compiled by the Agency or
- for which there are Community workplace exposure limits.
The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market. The regulation details the obligatory headings of the SDSs. A SDS shall be provided free of charge on paper or electronically. Suppliers shall update the SDS without delay if:
- new information on risk management or on hazards becomes available
- an authorisation has been granted or refused
- a restriction has been imposed.
Information on substances for which SDSs are not required must be communicated accordingly as well. Workers and their representatives shall be granted access by their employer to the information on the substances or mixture that they use or may be exposed to in the course of their work.
Each manufacturer, importer, downstream user and distributor must keep every information compiled, for at least 10 years after cessation of production, supply or use.
In making a use known, the downstream user shall provide sufficient information to allow the manufacturer, importer or supplier of the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the chemical safety assessment. If this use cannot be incorporated, the Agency and the downstream user must be informed. A downstream user shall prepare a chemical safety report ( Annex XII) for any use outside the conditions described in an exposure scenario or, if appropriate, for a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. Downstream users shall keep their chemical safety report up to date and available.
The regulation details the evaluation process and authorisation. Holders of an authorisation as well as downstream users shall include the authorisation number on the label before they place the substance or a mixture containing the substance on the market for an authorised use. Substances in Annex XVII shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to scientific research and development. The regulation details the restrictions process.
The Secretariat of the Agency shall:
- make the information identified in the database(s) publicly available, free of charge, over the Internet;
- provide technical and scientific guidance and tools for the operation of this regulation;
- advise and assist manufacturers and importers in registration.
This Regulation shall not apply to:
- radioactive substances;
- substances, which are subject to customs supervision and are in temporary storage, etc.;
- non-isolated intermediates;
- the carriage of dangerous substances;
No risk (e.g. water, sugar. Annex IV), unmodified, non-dangerous substances which occur in nature (e.g. ores, vegetable oils) and byproducts of unintended reactions (Annex V) are exempted from registration and evaluation.
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: And V Exemptions from the obligation to register in accordance with article 2(7)(a) and (b)
Annex VI: Information requirements referred to in article 10
Annex VII/VIII/IX/X: Standard information requirements for substances manufactured or imported in quantities of one tonne or more / 10 tonnes or more / 100 tonnes or more / 1 000 tonnes or more
Annex XI: General rules for adaptation of the standard testing regime set out in annexes VII to X
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, mixtures and articles
This legal act is a regulation thus applying directly in the Member States - no national implementing measures are required.
Due to the continuously evolving legislation, to get the latest Regulation we recommend to consult the REACH Legislation page of the website of ECHA.