Showing posts with label REACH registration. Show all posts
Showing posts with label REACH registration. Show all posts

Saturday, September 17, 2011

REACH Registration Beginners' Guide

REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than 1t/year to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration; however, non-EU companies may submit registration by appointing an EU-based Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.

The Scope of REACH Registration

- Substances manufactured/imported above 1t/y on its own or in preparations;(Note: some substances are exempted.)
- Substances in articles if present above 1 t/y and intended for release(for example, ink a pen);
- Monomer substances if present at a concentration above 2% in a polymer(for polymers, monomers shall be registered);
- Intermediates - reduced requirements and lower costs;
- Substances subject to Product and Process Oriented Research and Development( PPORD ) exempted from registration for 5 (+ 5) years; However, PPORD notification needs to be submitted.

The Deadline of REACH Registration

Substances can be categorized into two groups under REACH: phase-in substances and non phase-in substances. Each group has different REACH registration deadline.

Phase-in substances("existing substances") enjoy benefits of extended registration deadlines if pre-registered before Dec 2008. The principle is that the higher the tonnage, the earlier the registration deadline. Substances classified as CMR1/2 or R50/53(100t/y+)need to be registered before 30 Nov 2010 (see next diagram).

Non phase-in substances("new substances not covered by the definition of a phase in substance") need to be registered immediately before being placed in the EU market.

More info about REACH registration can be found below:
REACH Registration

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration and restriction requirements. Please refer to Swiss Chemicals Ordinance (ChemO) and Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.

Wednesday, October 20, 2010

How much does REACH registration cost?

REACH late pre-registration is cheap. The market price is between 100 Euros to 500 Euros per substance with discount available for multiple substances. If you appoint an only representative, you need to pay annual maintenance fee on a yearly basis, probably between 100 Euros and 500 Euros per substance per year(discount is also available).

REACH registration is much more expensive. The total cost of registering one substance could reach millions of Euros if your tonnage is very high and your company is the only company registering it. Luckily, REACH encourages data sharing through joint submission, in which case lead registrant and consortium will do most of the work such as GLP testing, preparation of technical dossier and Chemical Safety Report. Member registrants only need to pay lead registrant a fee (i.e, buying a letter of access) to refer to the joint registration data and dossier developed by lead registrant or consortium, and prepare their individual part of registration dossier.

REACH Registration Cost Estimation
The total registration costs mainly consist of three parts:

A.Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is dependent on tonnage band. Data fee varies from substance to substance. It is fixed by consortium or lead registrant. It is also tonnage based.The price of a letter of access for a typical substance is between 2,500 and 15,000 Euros. For example, the letter of access for Iron costs 2500 Euros for 1000t/y+. The letter of access for many petrochemicals cost 10,000 Euros per substance.


B.Consultancy fees paid to consultancy firms to advise the whole registration process and prepare the individual part of registration dossier in iuclid 5. The service fee covers SIEF/consortium communications, data gathering, individual dossier preparation and submission. Some firms charge hourly rates. CIRS usually charges a maximum of 4,000 Euros for this service if Chemical Safety Report(CSR) is part of joint submission. If CSR is not included, CIRS charges extra fees for CSR (8,000 Euros).


C.ECHA fees paid to European Chemical Agency. The fee is dependent on the annual tonnage of the substance and company size. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).

For more information, please go to:
http://www.cirs-reach.com/REACH/REACH_Registration_Costs_Fees.html