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Paul Machin on REACH
"REACH" (Registration, Evaluation, Authorisation and restriction of Chemicals) is a European Union Regulation that is highly likely to affect every, chemical producer, printing product supplier and printer that sells in Europe. It requires every substance whether sold on its own or incorporated into a product to be pre-registered with the European Chemicals Agency in Helsinki by 1st December 2008.

The Implications of REACH Print E-mail
Tuesday, 21 October 2008
Failure to register will mean no sale within the EU.

There are a number of implications that will follow on from this regulation. Since registration will be costly this financial burden will be passed down the supply chain leading in some cases to the withdrawal of chemicals from the market place. Failure to understand the ramifications of REACH can have disastrous effects upon the future of many screen and digital printers as well as their suppliers.

There is help available. FESPA itself has been staging presentations on REACH around the world. There is free guidance provided to assist all sectors of the industry. This forum will be able to channel members to get the right information to insure their business does not fail to meet the REACH challenge and lose a valuable market.


FAQ: Implications of REACH for Screen & Digital Printers

Who could be affected by REACH?
Apart from consumers everybody in this industry who has any commercial dealings with Europe is likely to be affected and needs to know what they are required to do.

What are the actions needed by the printers who sell products to customers in the EU?
It is necessary to confirm that inks and other products they use do not contain chemicals that are carcinogenic, mutagenic, repro-toxic or toxic to aquatic environment in the article at a level of greater than 0.1% or any chemical that can be emitted into the environment during its entire life cycle. Examples of potential problems where registration is likely are digital ink cartridges and machinery containing lubricating oils, lead-based and some UV curing inks. To ascertain whether any very hazardous chemicals are included in the products it will probably be necessary to contact your suppliers. The hazardous nature of the chemicals used will be declared on the containers under the new Global Harmonisation System – a world-wide transport and hazardous labelling system that will shortly be introduced.

What are the ramifications for printers selling products?
If any ink, substrate, consumable or machinery manufacturer has to make a registration they will endeavour to recover those costs from their customers who will pass this charge down the supply chain. If chemicals are withdrawn because of cost, substitution will be needed that could affect the product performance.

Do digital ink cartridges need to be registered?
They are considered as articles that will emit chemicals during their entire life cycle and must be registered.

NEW - When will we know which substances have been pre-registered?
The European Chemicals Agency (ECHA) has published on its website a list of pre-registered substances. The list contains about 150,000 substances which were pre-registered by 65,000 companies between 1 June and 1 December 2008. ECHA has been screening part of the information submitted and due to the high number of pre-registrations ECHA will continue to check the information into the New Year. The fully screened list will be published at a later date.
 
It is possible to download the list at the following web site address:
http://echa.europa.eu/doc/press/pr_08_58_temp_submission_closed_20081216.pdf
This is a large file and access can be slow.

Further information on the pre-registration process can be accessed at:
http://echa.europa.eu/doc/pre-registration/pre_reg_qa_en.pdf
 

Paul Machin & REACH

Paul MachinPaul started in the printing industry in 1970 having already spent 15 years in the surface coating industry and is a qualified chemist and lawyer...
Read more...
Do you have questions about how REACH will affect you and your business?
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A selection of questions from fespa.com visitors and Paul's answers is published below:

Question:
How does REACH affect digital ink cartridge suppliers outside the EU and wish to sell in Europe? Answer:
Manufacturers of digital cartridges containing ink are not considered as articles and therefore all constituents of the ink must have been registered if sold or used within the EU. The manufacturers of such digital ink cartridges are considered as being Downstream Users. The Downstream User must check that every raw material used in the production of these digital ink cartridges have been pre-registered with the European Chemical Agency in Helsinki. Without this pre-registration no products can be sold in the EU.
There are certain exceptions:
1. polymers that contain less than 2% of free monomer,
2. if the total quantity of each raw material supplied by the Chemical Manufacturer that is exported directly or is present in any preparation sold in the EU is less than 1 tonne per year and does not contain a Substance of Very High Concern (SVHC).
The Downstream User is also obligated to advise the Chemical Manufacturer of the use of each and every chemical that is used by the Downstream User. If the total sales exceed 1 tonne per annum failure to pre-register the use will result in the Downstream User having to undertake a postcard registration themselves. The Chemical Safety Assessment which is an integral of the Chemical Safety Report must be completed by the manufacturer/importer prior to any registration for chemicals supplied to EU that exceed 10 tonnes per year. The Chemical Safety Assessment must show that the chemical can be used safely for all identified uses throughout the chemical life cycle. The chemical life cycle covers all uses of the substance on its own, in preparations and in articles or products. This requirement does not exclude the need to provide the standard 16 section EU safety data sheet or labeling the product in accordance with the EU Directives associated with substances and preparations.

Question:
Are substances that have been registered with the European Chemicals Agency (ECHA) in Helsinki and exported outside the EU exempt from further registration if subsequently they are then sold in the EU?
Answer: Substances which have been registered, exported and then re-imported are exempted from registration and evaluation under certain conditions. The following conditions must be fulfilled to benefit from this exemption:
1. The substance must have been registered before it was exported from the Community. This means that if, for some reason, the substance was not registered at the manufacturing stage, the substance has to be registered upon re-import.
2. The substance already registered and exported must be the same, i.e. have the same chemical identity and properties, as the substance being re-imported, on its own or in a preparation. For example, if the exported substance itself was modified outside the EU and therefore it is not the same substance which is now being re-imported, the re-imported substance has to be registered. Substances that are re-imported will in time have been registered. It is therefore possible to use the appropriate reference numbers in any declaration such as a safety data sheet.

Question:
Do products such as polyester fabrics require registration under REACH?
Answer: Fabric manufactured from polyester, nylon, PVC, acrylic etc. is considered to be an article. Articles do not require to be registered under REACH unless the articles contain Substances of Very High Concern (SVHC) in quantities that exceed 0.1% or they intentionally emit substances during their life cycle and it exceeds 1 tonne per year. An example of the latter could be scratch off cards or ink cartridges.
Polymers containing less than 2.0% monomer or polymers with greater than 2.0% monomer but having sales lees than 1 tonne per annum are excluded from the requirements of registration.

Find out which actions you need to undertake to ensure compliance with our REACH Decision Tree
 
For further information, visit the Europa REACH website
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