What is REACH registration and how much it will cost you

"There is a general obligation for manufacturers and importers of substances to submit a registration to the Agency for each substance manufactured or imported in quantities of 1 tonne or above per year. Failure to register means that the substance is not allowed to be manufactured or imported."

- From the European Commission Guidance Document of Feb 2007

Pre-registration and Registration: Who has to register?

EU manufacturers / importers of substances over 1 tonne/year;
Only Representatives appointed by non-EU companies;
Learn more about if you qualify for late pre-registration.

Pre-registration and Registration: What to register?

Substances above 1 ton per producer/importer per year on its own or in preparations;
Substances in articles if present above 1 ton, dangerous (67/548/EEC) and intended for release;
Non-registered monomer substances if present at a concentration above 2% in a polymer;
Isolated Intermediates - reduced requirements for on site or transported isolated intermediates ;
Substances subject to Product and Process Oriented Research and Development(PPORD ) exempted from registration for 5 (+ 5) years;
Exemptions: polymers, Annex IV&V, radioactive substances, waste and re-imported substances

Pre-registration and Registration: When to register?

Substances can be categorized into two groups: Phase-in Substances and non Phase-in Substances. Phase-in substances("existing substances") enjoy benefits of varied extended registration deadline if pre-registered while non phase-in substances("new substances") need to be registered immediately before being placed in the EU market. The principle is that the higher the tonnage is, the earlier the registration deadline is.

deadline

The picture in the left shows varied registration deadlines for substances with different tonnages and hazard properties. Eg, substances above 1000 ton per year or substances with classification of CMRs or R50/53s need to be registered before 30 November 2010. Substances with a tonnage between 100 ton per year to 1,000 ton per year need to be registered by 31 May 2013.

REACH Registration: What is registration dossier and what data is needed?

To complete registration, a registration dossier needs to be made by a software called IUCLID 5 and submitted to the Agency for evaluation. A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.

Technical Dossier (> 1 ton per year)

Identity of manufacturer/importer;
Identity, volume and identified uses of substance;
Classification and labeling ;
Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, etc);
Testing proposal;
Statement whether tests have been carried out on vertebrate animals;

Chemical Safety Report (> 10 ton per year)

Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
Exposure Scenario is required if classified as dangerous or PBT/vPvB;
- operational conditions and risk management measures for each use;
- exposure estimation;

REACH Registration: Joint submission and typical registration process

The good news about registration is that not every registrant is required to gather data, conduct testing and prepare a complete registration dossier. To minimize animal testing and data cost, REACH encourages data-sharing among all registrants by joint submission. During joint submission, lead registrant or consortium will do most of the work such as dossier preparation and development of exposure scenario, and submit joint dossier to ECHA. Other co-registrants only need to pay the lead registrant or consortium a fee to refer to the joint dossier and prepare the individual part of the registration dossier in IUCLID 5.

There are two different regimes that make data-sharing among pre-registrants possible: SIEF Process and Inquiry Process. SIEF process applies to pre-registered phase-in substances. Inquiry process applies to phase-in substances that missed the pre-registration deadline and non-phase-in substances.

Typical Registration Process For Phase-in Substances

Substance is pre-registered;
All pre-registrants of the same substance are put into one Substance of Information Exchange Forum(SIEF);
SIEF facilitator conducts survey on substance sameness and data availability;
Lead registrant is elected by all SIEF members (in many cases, LR is a large company or a member of a consortium);
Lead registrant collects data, prepares joint registration dossier and Chemical Safety Report;
SIEF member pays lead registrant (buys a letter of access) to refer to the joint registration dossier;
SIEF member completes the individual part of registration dossier in IUCLID 5 and submits it to ECHA;
SIEF member pays ECHA administrative fee and receives registration number;

Typical Registration Process For non Phase-in Substances

Inquiry dossier is submitted to ECHA to see if data is available or if there are other potential registrants;
Registrant negotiates the cost of data with previous registrant or other potential registrants and reaches data-sharing agreement;
Registrant collects the rest of data needed (usually by testing), prepares registration dossier and submits it to ECHA;

Make A Right Registration Decision: Purchase A Letter of Access VS Join REACH Consortium

For any registrant who is not willing to take the lead registrant role to finish registration, there are two options: Puchase a letter of access as a member of SIEF or join REACH consortium. Read more about the difference between SIEF and Consortium and find out which option works better for your company.[pdf, 697k].

REACH Registration Fees and REACH Registration Costs: How much will it cost you?

Registration cost is a major issue to consider before deciding whether to register or not because registration could be very expensive. Our cost-analysis model is based on our experience and shall allow you to estimate how much registration might cost you. Read more about REACH registration costs and REACH registration fees[pdf, 298k].

Hint: Besides registration, you can also learn more about your other obligations under REACH & CLP. If you are a non-EU company, you might also need our Only Representative service.

Our REACH Registration Services

Our full-range REACH registration services will provide end-to-end solutions to REACH registration. We have acquired 9 registration numbers and will continue to help you get your own registration number at a minimum cost. Focusing on small and medium sized enterprises, we will help you minimize total registration costs by giving you expert advice and only charging necessary and reasonable fees for our work.

Should this service be of any interest to you, please contact yunbo.shi (at) cirs.ie or give us a quick call at +353 41 9806 916 for advice.

SIEF/consortium Representation;
Data Search and Data Gap Analysis;
Preparation of Inquiry Dossier in IUCLID 5;
Preparation of Partial or Full Technical Dossier IUCLID 5;
Preparation of Chemical Safety Report (Exposure Scenario if required);
Preparation and Translation of Safety Data Sheets;

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