REACH at a glance
What is REACH?
REACH is the European Chemicals legislation. REACH compliance is complicated. Most of the chemicals marketed in the EU are subject to REACH Registration. For Substances of Very High Concern (SVHC) strict rules apply.
Extended Safety Data Sheets and REACH notifications to ECHA are also REACH requirements. Learn more: • REACH at a glance • The REACH Executive Summary
R E A CH = Registration Evaluation Authorisation ChemicalsREACH is the European chemicals legislation. It applies in all 27 EU countries plus Norway, Iceland and Liechtenstein. It does not apply in Switzerland.
RegistrationAlmost every chemical marketed in the EU in a quantity over 1 ton per year will have to be registered under REACH. Registration involves submitting a large and complicated technical dossier. New substances must be registered immediately. ‘Phase in’ (i.e. existing) substances may be registered spread out over time. The timing depends on the volume and toxicity. Pre-registration is needed to enjoy the REACH delays for existing substances.
EvaluationRegistration dossiers for large volume chemicals will be evaluated by competent authorities
AuthorisationSubstances of Very High Concern will be subject to a system of permits (REACH Authorisation).
Other REACH obligationsREACH also brings about many smaller obligations. For example: Extended Safety Data Sheets, requirements for users of chemicals and notification to ECHA of certain substances in ‘articles’ (objects).
Warning!The REACH legal text counts almost 1.000 pages. The REACH Technical Guidance Documents count almost 20.000. This web site just scratches the surface!
Read more about:• Substances, mixtures and articles • Scope & REACH exemptions • Pre-Registration • Registration
• Evaluation • Authorisation and the Candidate List of Substances of Very High Concern • EU, EEA and Switzerland • Imports and REACH Only Representative
REACH distinguishes between ‘Substances’, ‘Mixtures’ and ‘Articles’. • A substance is a chemical element or compound obtained from a chemical manufacturing process. • A mixture is exactly that: a mixture of substances. • An article is an object with a special shape, surface or design. Most of the REACH obligations apply to substances: both ‘on their own’ and in mixtures.
Distinction between substances and mixtures on one hand and articles on the other, is not always self-evident. There are complications like ‘Articles with an intended release’ and ‘Mixtures in a sophisticated container’ (ink in pens). Some specific REACH obligations apply to articles. Articles may be subject to REACH Restrictions. When they contain Candidate List Substances, it is required to communicate with customers and send a REACH notification ECHA. For more information about Articles see our dedicated web page: ‘REACH and Articles’.
All the substances marketed in quantities over 1 tonne per year (per legal entity), are in scope of REACH, unless they are explicitly exempted. The biggest exemption is Polymers. But this is not as good as it sounds! The polymers themselves are indeed exempted, but the monomers and most of the additives that were used to make them, are not.
Also exempted: several groups of substances that are already well regulated or well known. For example: biocidal products, radioactive substances, minerals, food and waste. For two specific end-uses, the REACH registration dossier need not cover the exposure to consumers: Cosmetics and Food Contact Materials. For more information see our dedicated web page: ‘REACH Scope and exemptions’
REACH Pre-registration is needed for existing substances. Without pre-registration, the competent authorities may demand immediate registration. REACH Pre-registration is mainly an administrative act. It distinguishes between ‘phase-in substances’ and new substances. Pre-registration brings all potential registrants of the same substance together in a virtual network called SIEF (Substance Information Exchange Forum). They are expected to exchange information, mainly to avoid animal testing, as much as possible.
Pre-registration is always necessary, even if there is no intention to register a substance in the futuure. The pre-registration deadline was 30 November 2008. Late pre-registration is possible for first time manufacturers and importers, and newly appointed Only Representatives. Forgot to pre-register? Contact us; we will find a solution. More information on our dedicated web page ‘REACH Pre-registration’.
Registration involves submitting a vast technical dossier with toxicological and eco-toxicological information, a risk assessment, recommendations on how to manage the identified risks, proposals for classification and labelling etc. Every substance marketed in the EU in a quantity of more than 1 ton per manufacturer or importer per year, must be registered.
Only European legal entities can register: European chemical manufacturers, European importers and the ‘Only Representatives’ for non-European chemical manufacturers or formulators. For registration deadlines see below. More information on our dedicated web page ‘REACH Registration’.
REACH Registration deadlines for Phase-in substances
Substance properties/Yearly Volume • CMR ≥ 1 t/y (Carcinogenic, Mutagenic, Reprotoxic Cat. 1 & 2. EU Risk phrases R45, R40, T/R46, R60, R61, T/R60 and T/R61) • Other substances ≥ 100 t/y • Other substances ≥ 1 t/y
Deadline Immediately Immediately 31 May 2018
Dossiers for large volume substances (> 100 tons per year) may be evaluated by Member State authorities.
As a result of this evaluation, registrants may be asked to revise parts of their registration dossier. More information on our dedicated web page ‘REACH Registration’.
REACH Authorisation The REACH Authorisation addresses Substances of Very High Concern. The substances subject to Authorisation are listed in REACH Annex XIV. This annex is regularly expanded. A manufacturer or importer of this substance must obtain a permit for using a substance subject to REACH authorisation. Permits are very difficult to get.
REACH Candidate List of Substances of Very High Concern Substances have a long way to go before they feature in REACH Annex XIV. They are first included in the REACH Candidate List of Substances of Very High Concern. Inclusion of a substance in the REACH Candidate List already leads to obligations. When mixtures contain candidate list substances, the industrial user and ultimately the consumer must be informed. Where articles contain Candidate List substances, REACH Notification to ECHA is often required. More information on our dedicated web page ‘SVHC and Authorisation’.
REACH applies in all the 28 EU Member States and in Iceland, Norway and Liechtenstein. Together they form the EEA (European Economic Area). Beware: Switzerland is not a member of EEA!
For special ‘European’ places like the Faeroe Islands and Guadeloupe it is not always clear what the European Customs Territory is. Exact descriptions can be found on the ECHA website.
REACH only addresses European companies: EU-based manufacturers and EU-based importers. Companies based outside the EU cannot themselves do registrations, notifications or whatever is necessary for REACH compliance. In the case of exports to the EU the following applies: • Default: the EU-based importer of the goods is fully responsible for REACH compliance. • Alternative: a REACH Only Representative is appointed by the non-EU producer.
The REACH Only Representative takes over most of the REACH obligations from the importer. The importer becomes a ‘Down Stream User’; as if he buys the products in the EU. More information on our dedicated web page ‘REACH Only Representative’.