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REACH Registration only applies to manufacturers and importers of ‘substances’. Coatings are generally ‘preparations’ and therefore do not require REACH Registration. You will however be responsible if you manufacture or import any of the actual substances used your coatings.
The testing requirements depend on the tonnage of the chemical manufactured or imported. The higher the tonnage in question the more tests need to be performed. The requirements are laid out in the Annexes of the REACH Regulations. Some of the more complex tests don’t have to be carried out ahead of REACH Registration but the Registration Dossier needs to contain proposals for carrying out the missing tests or arguments for not having to perform them.
This chemical would be described as an ‘Intermediate’. There are reduced REACH Registration requirements for Intermediates but it will still be important to register them.
Perhaps the most important thing you must do is to pre-register your substance in the six month window starting in June 2008. If you fail to pre-register your substance, you will not be allowed to market it without taking it through full registration immediately.
REACH encourages manufacturers and importers to work together to submit a joint registration dossier. The preparation work will be carried out in a Substance Information Exchange (SIEFs). One of the drivers for this is to minimize animal testing. Companies will need strong arguments for working alone outside the SIEFs.
Yes you do. REACH requires that anyone who manufactures or imports a chemical such as a dye, registers that chemical. Importing companies are often small companies without in-depth chemical expertise, but the argument is that chemicals should not be imported into the EU for which there is little information on the hazards of that chemical. The alternative to each importer of the same dye having to register that dye is for the Chinese dye manufacturer to appoint an ‘only representative’ in the EU to do the registration. This will then remove the registration requirement from the importer who now becomes a Downstream User under REACH.
Providing that you do not manufacture or import any actual chemicals ‘substances’ and just use ‘substances’ to make mixtures (in your case cleaning products) then you will not have to register any chemical substances. Take care however to have an expert study your manufacturing process and ascertain whether or not you may be manufacturing any chemicals in your production processes. If you just use chemicals then you are classed as a ‘Downstream User’. As a downstream User you still have REACH obligations. You will need to feed information back to the chemical manufacturers on how you use those chemicals so that they can register your ‘use’. You will also need to feed information back up the supply chain on ‘exposure’ to that chemical i.e. worker and possible consumer exposure. This will enable the manufacturers to work though the ‘exposure scenarios’ and in turn provide you with information on how to handle that chemical in the form of a Chemical Safety report.
You will be seen as an importer of ‘articles’. Your obligations are outlined in REACH Article 7. If you import articles that are designed to purposely emit chemicals such as inks then you will have a duty to register those chemicals providing certain other criteria are met e.g. the chemicals in the ink have not already been registered for that use. You will also need to check whether your articles contain any ‘substances of very high concern’ that could ‘foreseeably be released during the life cycle of the product’. In this instance you would have a duty to ‘notify’ the authorities who may in turn ask you to register those chemicals.
Plastics (polymers) are presently excluded from REACH but any monomer that has been above 2% used to manufacture the polymer must have been registered under REACH. For EU manufacturers of polymers this should not be an issue as all chemicals used in their manufacturing process will have to be REACH registered (with some minor exceptions). For importers of plastics however they will need to ensure that the chemicals that were used to manufacture the polymer have been REACH Registered.
Perhaps the first thing to understand is that ‘authorization’ will work in parallel to the registration procedure and not follow on after it. A list of substances fulfilling the criteria for ‘substances of very high concern’ will be drawn up by the authorities. These will be substances such as carcinogens, mutagens or reproductive toxins and substances that are persistent, bioaccumulative and toxic in the environment. This will be called the candidate list and will probably number in the order of 3000 substances. The authorities will then take a certain number of chemicals on the candidate list forward each year, maybe in the order of ten to twenty per year through the full authorization procedure. Manufacturers of the authorized chemicals will only be able to continue to manufacture and market them if there are no safer substitutes, exposure is restricted or there is a strong socio-economic argument for continuing to use that chemical. Manufacturers will also need to prove that there are research programs in place to find safer substitutes. Even when authorizations have been granted they will only be for certain restricted end-uses and for a certain period of time.
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