Biocides have special approval rules rather that being regulated under the EU’s chemical control system REACH. The EU has decided safety assessments have to look not just at biocidal active ingredients and their combinations, but also at the finished products. The new regulatory procedure, which comes into force on 1 September 2013, is designed to take biocides with a damaging environmental impact off the market
In terms of EU legislation, biocides are viewed as a special case because of their nature and purpose. Now is the time to check whether biocides currently in use will remain available under the new regulation.
It is perhaps a cruel irony that biocidal chemicals used by cleanroom managers to produce a pristine environment should have such a complex – some might say messy – regulatory system in the European Union (EU). But it is the truth.
Biocides are not treated like other chemicals, which are generally regulated under the EU’s chemical control system REACH. They have special approval rules – governed until 1 September 2013 by the EU biocidal products directive (BPD) 98/8/EC1 and from that date by EU regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products. Regulations must be followed to the letter by member states, unlike Directives where they have more leeway over implementation.
Why the need for these special controls? Simply put, it is because biocides are designed to kill organisms or stop them from spoiling products and so are inherently toxic. As a result, the EU has decided safety assessments have to look not just at biocidal active ingredients and their combinations, but also at the finished products – just to make sure biocides kill or preserve only what they are supposed to kill, and nothing else, notably cleanroom staff.
And cleanroom managers really do need to pay attention, because of the key role played by biocides as disinfectants, sanitising agents, sporicidal agents and sterilants. And given the wide variety of requirements across cleanrooms, sometimes only specific biocides can do the job. For instance, while alcohols kill bacteria, mycobacteria, fungi and viruses they have limited sporicidal efficacy. And while quaternary ammonium compounds cannot destroy bacterial spores or mycobacteria, guanidines wipe out Gram-negative bacteria. So ensuring a cleanroom’s specialist biocide is legal – or is destined to remain legal under the EU’s biocidal products regulation – is an important job for compliance officers and buyers.
The problem, noted Neil Harvey, secretary of the biocidal producers network of the UK’s Chemical Industries Association (CIA) is that the new regulatory procedure, which is designed to take biocides with a damaging environmental impact off the market, is pretty tough and expensive.
As a result, he said: ‘The worry is that niche products [for instance some used by cleanrooms] may be taken off the market for economic reasons and not for legitimate environmental reasons. Because the process is so expensive, perfectly good products are being removed from the market because manufacturers cannot afford to put the products through the approval procedures.’
Perfectly good products are being removed from the market because manufacturers cannot afford to put the products through the approval procedures
And hence an understanding is important of how the regulation’s assessment and approval procedure works, which has been carried forward with some important improvements from the directive. Both laws not only set up harmonised systems for approving new biocidal ingredients and the products based on them, but also for a review of existing biocides and their ingredients, to make sure they are safe. If they are not, then the review process is supposed to prevent their sale.
Speaking to Cleanroom Technology, the chair of the new biocidal product committee of the European Chemicals Agency (ECHA), Erik Van de Plassche, said the agency would be maintaining an up-to-date online list of biocides deemed safe, which can be monitored by cleanrooms.
Of course, managers using biocides may want to know in advance if there is a risk their products might end up being banned and Van de Plassche said, maybe less helpfully: ‘How to assess before whether the product will have a chance of surviving [the review]? You would have to contact your supplier.’ For under the regulation (and the directive) it is the manufacturer, importer or seller of a biocide (or its ingredients) that has the responsibility for securing authorisation under the system. This is a key difference from REACH, where users have a key role in its controls.
Harvey concurs: ‘Cleanroom managers should be asking their suppliers whether or not they are [going to] get the product approved under the BPR [biocidal products regulation].’
Cleanroom managers should be asking their suppliers whether or not they are going to get the product approved under the biocidal products regulation
As for the review of existing biocidal products, this has been established because until the directive was in place, many member states did not have special biocide assessment systems, placing such products on the market as they would any other chemical. The directive has forced them to create such controls and this has been difficult for some governments who have lacked sufficient expertise or capacity – a particular problem for smaller and poorer EU states.
This has been, said Van de Plassche, a key reason why the review system established under the directive has often been subject to significant delays. ‘There was not much experience…on biocides in member states. They didn’t have a system in place. It was the first time they were dealing with an evaluation or assessment of biocides – a lot of methodologies had to be developed. This was the reason it took a long time,’ he added, pointing to the stage under the directive and the regulation where a committee of member state representatives had to sign off on the safety of biocide ingredients and combinations of ingredients.
There is hope that the job of assessing all EU biocides will now get done, albeit by 2024
This is now the job of the ECHA committee that he heads. And while all member states can appoint a representative if they wish, it will be armed with more experience as a result of the directive. Importantly, its deliberations will be time limited under the regulation, so unconfident officials will not be able to spin out an assessment. The committee must give an opinion on a biocidal active ingredient (or combination of ingredients) within 270 days.
There was no such cap under the directive and decisions sometimes took years – even up to four years, said Van de Plassche. So there is hope that the job of assessing all EU biocides will now get done, albeit by 2024. In that time, there will be 700 active substances (and combinations) that will need checking for safety, along with the products that are based on them.
How will the system work? It is worth cleanroom managers knowing the various stages, because it will give them the opportunity to check with review participants about how their biocides are getting on in the review.
A manufacturer, dealer or importer starts the process by selecting a national regulator to make an initial assessment of their active ingredient (or combination). That member state then passes a complete dossier to the ECHA, whose biocidal product committee gives its recommendation, to be passed to the European Commission for final approval (or rejection) of an ingredient or combination of ingredients. Then a company must secure a separate authorisation for a biocidal product based on an approved ingredient.
Here they have two choices. Either they can send their application to the ECHA committee, which will then make a recommendation to the Commission, or they approach a national regulator, who can approve it for use in their member state – if that goes through then easier ‘mutual recognition’ applications can be made with other member states.
One key issue is that under the regulation and the directive, national procedures have to be carried out under set EU standards
One key issue here is that under the regulation and the directive, these national procedures have to be carried out under set EU standards – whereas before such controls might have been weak or non-existent. Also an important safeguard under both laws has been that until these assessments take place, all biocides that are already allowed under national legislation can continue to be used.
Meanwhile, the regulation also provides for controls over new products and active ingredients, which mirror those used in the review. And the law insists that new market approvals made under the review and new product applications are temporary (five or 10 years generally), so ultimately all biocides will be subject to continuous reviews to ensure they are safe, allowing for new scientific knowledge to be taken into account in controls.
The key difference with the directive for both processes is the new central EU procedure for products, which is designed to speed up assessments.
Ultimately all biocides will be subject to continuous reviews to ensure they are safe
‘The advantage is that you get an authorisation for the whole European market,’ said Van de Plassche – something that is clearly useful for major companies operating cleanrooms across the EU. However, where companies know they are supplying only one country or a small group of countries, using the national assessment and mutual recognition procedure could still have value.
Access to the EU central system is not automatic from 1 September, however. From that date it covers only biocides including human and animal hygiene agents such as soaps and disinfectants. From January 2017, it covers key cleanroom biocides, namely ‘products used for the disinfection of surfaces, materials, equipment and furniture’ and ‘products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties’. That deadline also covers chemicals keeping medical devices clean. Only for biocides that kill birds, fish, and animals, plus anti-fouling products does the old dual EU-national system have to be used – but these chemicals are of little interest to the cleanroom sector.
A note from the ECHA has stressed how it will try to ease this process through the creation of a dedicated IT platform, the Register for Biocidal Products (R4BP), which will be used for submitting applications, exchanging data and information between the applicant, the ECHA, member state competent authorities and the European Commission. It will also document decisions and deliver information to businesses, including cleanrooms, and consumers.
Welcoming the imminent regulation, an ECHA communiqué said its goal was to ‘harmonise the market at EU level, simplify the authorisation and approval of active substances and introduce timelines for… evaluations, opinion-forming and decision-making. It also promotes reduction in animal testing by mandatory data sharing and encouraging the use of alternative testing methods.’
One important element of the new biocides regulation that might be of interest to hospitals using nanotechnology-based biocides, such as nano-silver impregnated materials, is that this is the first piece of EU legislation that introduces nanomaterials as a legal concept. It uses the EU’s formal definition of a nanoparticle – between 1 and 100 billionth of a metre.
And the regulation gives the ECHA and other regulators some wriggle room to change their assessments of biocides containing nanoparticles if science shows these tiny materials to be more dangerous to human health and the environment than has been accepted thus far. The regulation states: ‘There is scientific uncertainty about the safety of nanomaterials for human health, animal health and the environment…’ And so it insists that regulators refer to international forums in assessing their safety.
Importantly, it allows them to insist that an active substance be approved only if it does not include nanomaterials.
Biocides whose primary use is for medical devices have to comply with other EU laws and not the biocides regulation
Another important issue is that biocides whose primary use is for medical devices, such as disinfectants primarily used to disinfect surfaces in hospitals and medical devices, have to comply with other EU laws and not the biocides regulation. These requirements are set out in Annex I to EU directive 90/385/EEC on active implantable medical devices; directive 93/42/EEC on medical devices; and directive 98/79/EC on in vitro diagnostic medical devices. The key here is whether biocides’ main use is for these medical purposes; if it has another more important use in another sector, then the biocidal products regulation will still apply.
The extent of the regulatory control is enough to give a legal compliance officer a headache – but Van de Plassche is clear why these special controls are needed: ‘It is because…we are dealing with products that are toxic by themselves. They are designed to have a certain action – they need to kill – like a rat. And they were not covered by historical regulations. It’s reasonable that there is a specific regulation for biocides.’