Now the preregistration period has passed, Hilary Ayshford spoke to SAFC’s Carole Garcia about the next phases of REACH
Although the pharmaceutical sector is less affected by the REACH regulations than other parts of the chemical industry, there could still be a few surprises in store for some manufacturers now that the deadline for pre-registrations has passed.
APIs and excipients that are already registered with the EMEA are not subject to the REACH registration process, but intermediates need to be registered, even though they are held under cGMP conditions and therefore exposure to people and the environment is already managed.
According to Carole Garcia, market segment manager, pharmaceutical raw materials at SAFC Supply Solutions, it is on these intermediates that pharmaceutical manufacturers should be focusing. ‘I would say that maybe they have not focused enough on the
systems used before producing intermediates: i.e. starting materials and reagents. And even if those starting materials and reagents are coming from suppliers within Europe, the pharma industry should make sure that they will still be available after 1 January 2009 once the pre-registration period has ended.’
In the case where the starting materials are coming from outside the EU, if a company buys more than 1 tonne a year, it has the status of importer and is responsible for the registration. However, if the supplier outside the EU has appointed a so-called only representative (OR), the OR will take on the administrative responsibility under REACH.
Another aspect of the regulation that may have been overlooked, says Garcia, is what happens if usage of a substance that is currently used for research or development purposes increases to the point where it exceeds the 1 tonne/year threshold. If it was not pre-registered before the deadline, even though it is currently exempt, the company runs the risk of increasing the time to market because of the need to go through the late pre-registration process, or in the worst case scenario, finding that the substance is not authorised.
‘This involves a lot of administrative work and the authorities are likely to look a lot more closely at late pre-registrations,’ Garcia warns. ‘And maybe not just for the substance in question but perhaps also at the company’s other pre-registrations.
‘This is why SAFC has asked its customers to provide it with forecasts of future usage, even if they are not using more than a tonne today.’
In January 2009 the European Chemical Agency (ECHA) is due to publish a list of all the substances that have been pre-registered. There are no guarantees that they will ultimately be registered, but it gives more time – months or even years – before the decision has to be made to register or not.
The ECHA will also start creating the Substances Information Exchange Forum (SIEF) and will ask the industry and the companies to work together to build the registration SIEF. Then in June 2009 the ECHA will publish the list of the substances submitted to authorisation.
At present only 15 substances are candidates for this list, only one of which – cobalt chloride, which is used in some biopharmaceutical processes – is likely to affect the pharma industry. Companies would therefore be well advised to find an alternative substance for cobalt chloride in manufacturing processes. Eventually the list is likely to reach around 300 products, out of the 30,000 substances and 40,000 intermediates expected to fall within the scope of the REACH regulation.
The aim is eventually to add to this authorisation list all the substances that are of Very High Concern (SVHCs) – carcinogenics, mutagenics, teratogenics. ‘One of the main pieces of advice I would give to the pharma industry is to avoid the usage of any SVHC and to try to find a substitute at the r&d phase rather than waiting five, six or seven years and then having to substitute it in a hurry at commercial scale,’ added Garcia.
The expected result is that there will be substances that will be banned; substances that will be permitted but for restricted use; and molecules that companies decide are not economically viable to register, and these will just disappear from the market.
The European Commission estimates that between 10% and 20% of molecules will disappear under the REACH directive and that the cost of a substance – depending on the volume of the molecule, its toxicity profile and the number of companies that request registration – will increase by between 5% and 10%.
Up to this point, the costs involved in REACH have been relatively small. Pre-registration costs were minimal – the time involved in preparing the documentation and the modest cost of the IT tool. Participation in the SIEF also costs very little beyond the time needed to collate the data. This involves obtaining the toxicological data and combining it with all the known uses of the substance to compile a risk assessment and advice on how to handle it to optimise human and environmental safety.
The aim of the SIEF is to reduce not only costs but also the amount of animal testing that will have to be carried out on these molecules and to make sure it is optimised.
‘This is the biggest change that the industry has ever seen from a regulatory point of view,’ said Garcia, ‘but we have time – not everything is going to change on January 1, 2009.’
REACH is there to harmonise the rules of each of the individual countries, to give better visibility, better understanding of the impact on the environment and human health and to make sure there is a workable regulatory framework in Europe.
It is also likely to result in better control of the supply chain. The chemical industry is saying that a number of small and medium sized companies will go out of business, either because they will be acquired or will cease trading, because they won’t be able to manage the cost or the complexity of the registration process, according to SAFC’s marketing director Amanda Halford. It may also reduce some of the more ‘entrepreneurial style’ trading in chemicals, particularly from places like China.
‘There are two alternatives with this legislation – you can either embrace it and use it as a driver for innovation in your business, or you just let it hit you and then try to fight with it,’ she said. The way forward now is not just to create a molecule that saves costs, nor to create one that costs more but that is more sustainable environmentally. ‘What we would like to do is find a molecule that saves us cost and is good for the environment.
‘The really important thing to remember is: no data, no market. If you don’t have your molecule preregistered and you don’t provide the data on the molecule, then there is no market for that molecule as it will not be allowed to be circulated in the European market.’
