REACH Registration, Evaluation & Authorisation of Chemicals. T. Pearson. What is REACH?.
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REACHRegistration, Evaluation & Authorisation of Chemicals
REACH is the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 and contains a number of deadlines which will be progressively implemented until 1st June 2018 when all aspects of the regulation will be fully in force.
REACH is an EU Regulation and is therefore also national law in all EU countries as it stands.
REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
Intended to encourage, and in certain cases to ensure that substances of high concern are eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available.
REACH replaces about 40 pieces of legislation with a streamlined and “improved” Regulation.
REACH aims to improve the current EU chemicals legislation, and end the distinction between 'new' and 'existing' chemicals.
All chemicals that were reported as being on the European Community market between 1st January 1971 and 18th September 1981 (those listed in EINECS - around 100,000) are called 'existing' chemicals and those introduced after 1981 (those listed in ELINCS - around 4,300) are called 'new' chemicals.
In the past, only ‘new’ chemicals needed to be tested, which has resulted in the continued use of many untested “existing” substances.
In effect both lists will now be replaced by a new REACH list.
The Commission has estimated 30,000 substances (excluding intermediates) will be registered under REACH (based on tonnages above 1 tonne/year).
Under REACH, each manufacturer or importer of chemicals into the EU in volumes of 1 tonne or more per year will have to register them with a new EU Chemicals Agency, submitting information on properties, uses and safe ways of handling them.
Each registration will attract a fee (payable to the Agency) in addition to the costs associated with the generation of test data. These costs will be shared between registrants of the same substance.
The evaluation process is performed by the authorities and is basically a
Regulatory compliance function
Use-specific authorisation will be required for chemicals that cause cancer, mutations or problems with reproduction, or that accumulate in our bodies and the environment (Substances of Very High Concern - SVHC’s) .
An Authorised substance may only be used for the particular application(s) specified by the Agency, otherwise its use is prohibited – No exceptions!!!
Each use-specific Authorisation attracts a fee payable to the Agency (additional to the Registration fee!!).
All activities with a substance which are not restricted are allowed under REACH unless the substance is included in the Authorisation system.
A substance subject to restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
Pre- Registration for Phase-in Substances
Pre-registration allows use of the transitional regime whereby full registration of phase-in substances may be delayed until the appropriate tonnage deadlines (2010, 2013 & 2018).
Limited information required and is free. Deadline - November 30th 2008.
Required - Substance name, CAS & EINECS numbers, name and address of the registrant (legal entity), the tonnage band and projected registration deadline.
Must be registered using EU software interface called IUCLID 5.
Must be done by the manufacturer or importer.
Components of Registration:
Technical Dossier comprising:
– Identity of the manufacturer or EU importer
– Identity, volume and use (in-house and customer) of the substance
– Phys.-chem., tox. and ecotox. data (depending on the production volume)
(Tests have to be performed !Obligatory data sharing of vertebrate studies between registrants of the same substance !)
– Chemical Safety Report (substances > 10 t/yr)
– Must submit proposals for additional testing (substances ≥ 100 t/yr)
Note -Registration applies to both hazardous and non-hazardous substances.
Chemical Safety Assessment & Chemical Safety Report
Required for all substances subject to registration in quantities starting at 10 tonnes, and documents the hazards and classification of a substance and the assessment as to whether the substance is PBT or vPvB.
A chemical safety assessment of a substance shall include the following steps:
(a) human health hazard assessment;
(b) physicochemical hazard assessment;
(c) environmental hazard assessment;
(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
Any registration we make requiring a CSR will require a significant amount of resource to carry out and compile.
We shall only be able to use substances, either for resale or blending, where the supplier has registered a ‘use’ which covers our application.
For example, if a supplier includes ‘Surface finishing’ in his list of identified uses we can use it. If not, then we must ask the supplier to add it to his list. If he chooses not to do so (he may decide the additional work he has to undertake in compiling additional Exposure Scenarios is not worth it) then we must undertake the additional work required and notify the Agency of what we are doing. Suppliers are not obliged to cover submitted uses if they choose not to sell to that particular DU.
As the decision to create our own Exposure Scenarios for a particular substance will again be resource hungry, careful consideration will need to be given to each case before taking this route. Should we not choose to take this option, then we cannot use the substance from that particular supplier.
Downstream Users’ Obligations
Downstream users who use an Authorised substance (SVHC) must notify the Agency that they are doing so (notification is a very simple procedure – simply write to the national authorities and tell them).
DUs of other dangerous substances using them outside the scope of the suppliers intended use must either:
– inform their suppliers of their or their customers’ use(s) so the supplier can prepare exposure scenarios for that use, including the identification of appropriate risk management measures.
– report their uses to the Agency if they use substances in quantities of above 1 tonne per year outside the conditions of an exposure scenario.
Some ideas of costs (still not finalised):
1-10 t/yr 10-100 t/yr 100-1000 t/yr >1000 t/yr
€ 20-50,000 150-350,000 400-450,000 0.5-2,000,000
CSA + CSR € 25,000 € 50,000 € 100,000
Authorisation Fee: 58000 € (per specified use)
Testing Costs: Likely to be between 35,000 €(1-10 tonne/yr low hazard substance) up to 2,000,000 € (> 10000 tonne/year SVHC substance)
Testing costs to be shared between registrants of same substance.
Final costs of Registration and Authorisation due to be announced June 2008.
Future Availability of chemicals
Many substances will be lost from the EU market as a result of this regulation.
Whilst many of these will be small volume specialist substances and/or those which pose a high risk to man or the environment, it is fairly certain that they will include some substances currently used by Supply Houses.
Despite assurances from suppliers that they will continue to support a particular product in the future, we must be prepared for such decisions to be overturned at short or no-notice.
In the case of proprietary products which we use as ingredients for our products, there are likely to be cases where manufacturers from outside the EU fail (or refuse) to give sufficient details for us to be able to check if they are registered – in such cases we may be unable to continue to import that material. It will then fall to the R & D function to source suitable alternative – if this is not possible we may have to withdraw the product.
Additional Costs for Supply Houses
REACH will inevitably lead to increased costs of chemicals within the EU as suppliers/importers/manufacturers pass their costs on down the chain.
Costs incurred by registration/testing for substances we must register.
Costs incurred byregistration/testing costs of any other substances we choose to register.
Part of the registration process involves the negotiation of testing costs between all registrants. This is likely to be complex and dirty – we may need to look at retaining professional consultants to do this on our behalf.
There are also likely to be additional internal resource costs in order to comply/cope with these regulation e.g H & S, purchasing, R & D.
Restriction on availability of goods
The regulation effectively imposes financial penalties on the importation of goods from outside the EU. This is likely to force most European supply houses to cease the practice of importing proprietary products and raw materials from outside the EU.
Each registration is likely to cost a minimum of €25,000 - 50,000 – at least double that for substances requiring Authorisation.
Loss of Confidentiality
REACH requires the inclusion of the registration details on SDSs even for substances/products which are non-hazardous. It is intended that these details will be made openly available on the ECA database.
We will inevitably be forced to disclose additional data on SDSs.
These will need to be significantly expanded to include Registration numbers, Authorisation numbers (if applicable), more detailed Intended Uses and Exposure Scenarios. As a result, these will require significantly greater time to prepare than at present.
These will need to show the Authorisation numbers for any SVHCs contained within the product.
The Globally Harmonized System (GHS)
The Globally Harmonized System of Classification and Labelling Of Chemicals will come into force in 2010 for substances and 2015 for mixtures. This forms an integral part of REACH and effectively completely replaces the existing EU classification and labelling systems.
It includes changes to the current warning symbols and Risk and Safety phrases used in current SDSs together with changes in the defining criteria. All our products will require reclassifying in line with GHS.
This will require even more information to be carried on a label. This will force us to either increase the size of our labels yet again or reduce the number of languages shown.