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EU REACH Registration 2018

By Little Pro on 2015-12-30 Views:  Update:2017-01-18

REACH registration is required for all substances manufactured in EU or imported into EU in quantities of one tonne or more per year. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal conditions of use. The last REACH registration deadline is 31 May 2018 for all >=1t/y substances.

For all registrations, a registration dossier has to be prepared and submitted electronically via REACH-IT to the European Chemicals Agency (ECHA). Normally, the registration must be successfully completed and a REACH registration number assigned to the registrant before a substance can be manufactured, imported or placed on the market.

Which substances need to be registered under REACH?

Registration is required for all substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer unless they are exempted. For polymers, monomers shall be registered.

The following substances are exempt from REACH registration:

  • Substances exempted from REACH regulation: radio-active substances, substances under customs supervision, substances used for national defense, non-isolated intermediates, wastes, etc.;
  • Substances regulated by other legislation: substances in food, medicinal products, plant protection products, etc.;
  • Substances in REACH annex VI: a list of exempt substances well-known to be safe (i.e., water, nitrogen);
  • Substances covered by REACH annex V: by-products, naturally occurring substances, impurities, etc.;

Who needs to register?

The following actors in the supply chain must comply with REACH registration requirements:

  • EU manufacturers and importers of substances on their own or in a mixture; or
  • EU producers and importers of articles containing substances intended to be released; or
  • "Only representatives" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU;

Only Representative: Under REACH, a natural or legal person established outside the EU, who manufactures a substance, formulates a mixture or produces an article can appoint an only representative to carry out the required registration of the substance that is imported (as such, in a mixture or in an article) into the EU (Article 8(1)). This will relieve the EU importers within the same supply chain from their registration obligations, as they will be regarded as downstream users.

REACH registration deadline

Different deadlines have been set for phase-in substances and non-phase-in substances under REACH. Phase-in substances have to be registered according to the following schedule if they were pre-registered before pre-registration deadline 1 Dec 2008 while non-phase-in substances need to be registered immediately. The last registration deadline is 31 May 2018 for all pre-registered phase-in substances.

REACH registration deadline 2018

Phase-in substances are mainly substances already manufactured or placed on the market before REACH's entry into force. Substances fulfilling at least one of the following criteria may be considered as phase-in substances.

  • Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
  • Substances listed in the European List of Notified Chemical Substances (ELINCS);
  • Substances listed in the No-longer Polymer List (NPL);

Non-phase-in substances are all other substances that do not fulfil any of the criteria above and they cannot enjoy extended registration deadlines. Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance first before they can manufacture or import the substance.

What if I have missed pre-registration deadline?

Phase-in substances that missed pre-registration deadline (1 Dec 2008) cannot benefit from extended registration deadlines and need to be registered without any delay.

Potential registrants who, for the first time after 1 December 2008, manufacture or import a phase-in substance in quantities of one tonne per year or more can still submit certain information to ECHA (late pre-registration) and benefit from the extended deadlines. Late pre-registrations have to be submitted within six months after the manufacturing or importing of the substance that exceeds the one-tonne threshold and no later than twelve months before the relevant registration deadline.

Type of Registrations under EU REACH

Pre-registration
  • For all phase-in substances>=1t/y;
  • Deadline: 1 Dec 2008;
  • Require info: registrant info, substance identity, volume.
Late Pre-registration
  • For manufacturing or importing phase-in substances for the first time in quantities>=1t/y;
  • Deadline: 12 months before relevant registration deadline;
  • Require info: registrant info, substance identity, volume.
Registration
  • For all substances>=1t/y;
  • Require info: registrant info, substance identity, physio-chemical data, toxicology data , eco-toxicology data and chemical safety report(CSR);
  • Data requirement increases with tonnage band;
  • CSR required for >=10t/y substances.
Inquiry
  • For phase-in substances which missed pre-registration deadline and non-phase in substances;
  • The purpose of inquiry is to get info on data availability, existing registrants and other potential registrants;
  • Require info: registrant info, substance identity;
Intermediate Registration
  • Applicable to >=1t/y intermediates produced or used under strictly controlled conditions;
  • Reduced data requirements:
    • 1-1000t/y: existing data;
    • >=1000t/y: 1-10t regular substance data;
    • CSR not required;
PPORD Notification
  • Substance subject to product and process orientated research and development (PPORD);
  • Limited info required;
  • Valid for 5 years and can be extended for another 5 years.

 

REACH Annex VII has set standard information requirement on REACH registration. This annex VII can be downloaded from here.

Statistics on REACH Registrations

Click the picture below to find out how many registrations have been submitted and whether your substance has been registered under EU REACH or not.

REACH registration statistics

Reference & Resources

Click here to access all references and resources for Europe including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities.

 

 Tags: Topics - EUREACH-like Regulation and Registration

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