28-May-2013

Licensed to kill

Abstract

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.

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