What to register?
According to the REACH Regulation, any company manufacturing in the EU or importing into the EU:
- A substance on its own;
- A chemical substance in a preparation (i.e. mixture of substances);
- A chemical substance intentionally released from articles (i.e. finished manufactured products)
that is above the threshold of 1 tonne per annum may have to fulfil the obligation of registration. REACH differentiates between phase-in and non-phase in substances and there are separate registration schedules depending on which criteria a substance fulfils. Certain exemptions also apply.
Who has to register?
The only actors in the supply chain with registration obligations are:
- EU manufacturers and importers of substances on their own or substances in preparations;
- EU producers and importers of articles
- Only representatives established in the EU and appointed by a non-EU entity to fulfil their obligations under REACH.
When to register: Non Phase-in Substance Registration
Phase-in substances are (i) all new chemical substances and (ii) chemical substances that have not been pre-registered (and thus are not subject to the phase-in transitional timelines). After June 1st 2008, all phase-in substances must be registered immediately before manufacture and import in the EU. This is in accordance with Article 5 of the REACH Directive which dictates a ‘No data, no market’ principle.
For non phase-in substances there are no SIEF facilities, so the initial steps required for registration of a non-phase in substance consist of:
(i) An inquiry process to ECHA to ascertain if previous registrants exist who may share existing data for generation of the technical dataset required in the dossier
(ii) If previous registrants exist, they are obliged to provide a list of the existing test data. If the existing test data is more than 12 years old, then the existing data is available for free. If the test data is less than 12 years old, then new registrants will have to negotiate with data holders for access, or repeat the relevant tests. However, duplication of animal studies is not permitted under REACH.
For further information on registering a non phase-in substance, please This e-mail address is being protected from spambots. You need JavaScript enabled to view it
When to register: Registration of Phase-in Substances
According to Article 3(20) of the Reach Directive, a phase-in substance means a substance which meets at least one of the following criteria:
(a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
(b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;
(c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified inaccordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this;
For businesses that have pre-registered, there are a series of staggered tonnage-based deadlines which are spread out over a period of 11 years. In summary:
| Deadline | Tonnage Band |
| 2010 | Registration of substances >1000 tonnes per annum Registration of CMR >1 tonnes per annum Registration of R50-53 >100 tonnes per annum |
| 2013 | Registration of substances 100 – 1000 tonnes per annum |
| 2018 | Registration of substances 1 – 10 tonnes per annum Registration of substances 10 – 100 tonnes per annum |
| CMR: Substances that are Carcinogenic, Mutagenic and toxic to Reproduction (Cat. 1 & 2) R50-R53: Substances that are very toxic to aquatic organisms |
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When a business has pre-registered, they are automatically placed in a pre-SIEF, by the REACH-IT system of ECHA. This allows them to exchange information relating to substance identity, testing data and co-ordinate the registration process in the most effective manner.
The first REACH deadline passed on 30 November 2010. ECHA received 20,723 dossiers specifically for this deadline, covering 4,300 substances, including nearly 3,400 phase-in substances. Almost 400 of these registered substances were classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and more than 150 substances were classified as very toxic to aquatic organisms (R50-53).
For further information on registering a phase-in substance, please This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
