"It’s time to revise legislation on biocontrol agents"

There is one important sentiment that all producers of biocontrol agents, big or small, have in common: they complain about legislation on product registration in the EU. ‘And they have a very good point’, Dr. Rüdiger Hauschild says. Hauschild is director, as well as head of the Biopesticides Department of GAB Consulting. This German Biocomes-partner was actively involved in more than half of all dossiers behind registered micro-organisms in the EU. ‘The data requirements in the current legislation go back to 2001. We’ve gained a lot of knowledge since then, so there are many good reasons to revise legislation by now.’

Worth the trouble
Before entering the discussion on where legislation should be revised, Hauschild wishes to stress that legislation may be a major hurdle, but not always a blockade. ‘There are still many companies that go through the trouble of registering a biological control agent. And these companies do make money, so yes, it is possible.’

‘On the other hand, I know of many other examples where small and medium size enterprises gave up on registering their products. Particularly products with a very specific target organism and, thus, a very low risk of side effects but a limited market size, can’t carry the financial burden of a dossier and the fees. Moreover, these products in some cases can’t be applied every year, because they target pests that do not manifest every growing season. In those cases the financial risk is far too big.’

In other cases, the procedures are just plain unrational. ‘Some organisms, such as Bacillus amyloliquefaciens or Trichoderma strains, may be registered as a fertilizer, or soil improver in fruit and vegetables, with very limited legal requirements. But if you apply that same organism in the same crops as plant protection, then the requirements are far more expensive and extensive.’

Rationalize procedures
The current procedures for registering biologicals are directly derived from the procedures for synthetics, Hauschild explains. ‘There are some crucial differences with respect to the risk assessment, though. In many cases, a biological product is not totally new to the environment. A synthetic agent is new by definition. Therefore, many toxicity data are not required for biologicals.’

But Hauschild sees many more options to rationalize procedure in registering biologicals. ‘Very often, a relatively simple literature search will already show that the risk of a particular component or microorganism is very low. As of 2011, the EU has a separate category for products, in which the active ingredients are evaluated as “Low Risk”. It would be a good thing if this “Low Risk label” could be applied earlier in the registration of an active ingredient, and thus save a lot of unnecessary trouble and costs. The International Biocontrol Manufactures Association, IBMA, rightly appealed for such a change in legislation.’

By the same token, Hauschild realizes that changing this legislation may be tricky. ‘There’s always the risk that other producers may hijack this new low-risk procedure to register products that are actually not that harmless. The European legislators should therefore probably include a “provisional” clause, to be able to tackle possible problems after registration.’

Time consuming
Apart from the cost of registering a product – European fees alone can add up to more than half a million euros – the length of the procedures between 3 and 5 years is also a big pain. Hauschild: ‘When a product is registered as ‘Low Risk’, the registration can be 15 instead of 10 years. But still, the unpredictability of the lengthy procedures is too risky for many small enterprises. The effect is that many valuable products that could lower the burden of synthetic agents to the environment never make it to the market.’

Source: Biocomes