One of the most common questions routinely asked regarding REACH is, “Did you pre-register that substance?” Let’s play truth or dare to find out what you should answer.
Did you pre-register that substance which is the main building block for your key product?
Pre-registration is the means by which potential registrants, EU manufacturers and importers of “phase-in substances” greater than 1 tonne per year, inform the European Chemicals Agency (ECHA) of their intent to register.
Truth: Because you pre-registered you can benefit from extended timelines in which you can prepare for and submit your registration dossiers without interruption of manufacturing or importing. You can continue to produce your key product for the EU market. Basically, if you pre-register a substance it provides additional time to organize the collection, sharing and assessment of available data and the collective generation of missing information as part of a Substance Information Exchange Forum (SIEF).
Dare: It is not a legal requirement to pre-register under REACH but manufacture and importation of phase-in substance without pre-registration or without immediate registration is in breach of the REACH regulation.
I have a substance with an EINECS number, can it be pre-registered?
Truth: Yes – only phase-in substances that meet any of the following criteria can be pre-registered:
- Listed in EINECS;
- Manufactured in the EU (not necessarily exceeding the amount of 1 tonne per year), but not placed on the market in the EU by the pre-registrant in the 15 years before 1st June 2007 (e.g. intermediates, R&D substances); or
- No-Longer Polymers (NLP)” and placed on the market before entry into force of REACH (1st June 2007).
Dare: All other substances are non-phase-in substances and cannot be pre-registered and shall be registered directly.
I am purchasing the substance from a supplier in France, do I need to pre-register?
Truth: You need not pre-register substances that you source from EU suppliers, because the EU manufacturer or importer shall register them to continue manufacture / import, (no data no market).
Dare: To ensure continuity of supply, it is advised to seek confirmation from the EU supplier that they have pre-registered or registered their substances.
It’s January 31st, 2013, haven’t I missed the pre-registration window which was from 1st June 2008 to 1st December 2008 inclusive?
Truth: No – REACH has built in the ability to late ‘pre-register” a phase-in substance. If you are in the situation that as a manufacturer or importer you have just crossed the 1 ton per year threshold for a phase-in substance for the first time, then you have 6 months to late preregister. REACH requires that a substance be preregistered 12 months prior to the relevant registration deadline. So for substances in the 1-100 TPA band, pre-registration must be completed by May 31st, 2017. Once preregistered and the “substance sameness” is confirmed, you will become a member of a SIEF and now have until May 31st, 2018 to register this newly imported substance.
Dare: Remember the important caveats of pre-registration, that it must be done within 6 months of crossing the 1 TPA tonnage and must be before May 31st 2017 for < 100 TPA substances. The pre-registration window for substance at > 100 TPA has closed. You must go straight to registration.
My company is located in Switzerland and we are going to be exporting a phase-in substance to the EU next year, so I can pre-register as the Swiss legal entity on the ECHA web-site?
Truth: Manufacturers and importers of substances outside the EU (e.g. Switzerland) cannot pre-register. Legal entities based outside the EU who export substances to the EU also cannot pre-register themselves; however those which are manufacturers, formulators or article may choose to appoint an Only Representative (OR) legal entity based in the EU to take on the REACH obligations of EU importers. An OR is a natural or legal person located in the EU territory having sufficient knowledge and expertise on the substances (e.g. handling).
Dare: If you are a distributor, then you cannot appoint an Only Representative. The ECHA guidance documentation states that non-EU Distributors cannot appoint an Only Representative to cover the supply of the products they place on the EU market. This is to avoid a non-EU Distributor using one OR registration to cover the supply of a substance from more than one source.
So getting back the first question, “Did you pre-register that substance?”
Truth: If you are still unsure of your registration status or need guidance in pre-registering your substance dossiers please contact us today for a free consultation today.
Dare: If you intend to continue to manufacture or import phase-in substances in quantities over 1 tonne per year after 1st June 2008 and failed to pre-register within the specified time period, to be compliant with the REACH regulation, you must either:
- Submit a registration immediately to ECHA after the inquiry process, or
- Immediately stop manufacture and /or import, or
- Restrict manufacture and /or import to amounts below 1 tonne per year
If you are in doubt about your particular obligations or would like to save time and have the H2 Compliance experts prepare your registration dossiers please contact us today for a free consultation today.
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