Legislation on biocides: reform belies expectations

The adoption of the Biocidal Products Directive in 1998 was reckoned as a big step towards the protection of men and the environment. It did not take a long time, however, until its operational weakness became apparent.

 

Industry has been faced with administrative barriers; procedures are cumbersome and expensive. The calls for revision were growing ever louder.

 

In June 2009, the European Commission adopted the proposal for a regulation concerning the placing on the market and use of biocidal products.

 

Since then the EU Council and the European Parliament have undertaken eager negotiations in order to agree on the legislative proposal in near future, maybe in 2011. Will it be a breakthrough?

 

The legislative proposal for a regulation on biocides claims to bring progress with special regard to harmonisation and effective functioning. Several experts at the Fresenius Conference questioned whether these aims would be achieved.

 

David Dillon (SC Johnson, UK) and Geoffrey Wilson (biocide law consultant, UK) explained the view of the industry and its concerns about the status quo of product authorisation: Products once authorised needed to be constantly modified to accommodate improvements in product safety, changes in formulation, delivery systems, packaging and labelling as well as changing business needs and consumer expectations.

 

Experts estimate some 50,000 biocidal products applications for the European market and an average of 0.5 changes per year and per product. Hence Member States could have to take up to 25,000 decisions per year, Dillon and Wilson warned at the Fresenius Conference.

 

“There is a need for implementing measures setting out criteria and procedures for amending existing product authorisations. These measures must be introduced within the proposed Biocidal Products Regulation,” the experts postulated.

 

Taking stock of ten years Biocidal Products Directive Andy Adams (Bayer Environmental Science, France) came to a sceptical conclusion: Less than ten percent of the active substance product types evaluations have been completed and almost zero products re-authorised.

 

Approximately 700 inclusion decisions remain to be taken and for each of these, a new wave of product authorisations will be triggered.

 

As exposure is central to the risk assessment Adams calls for addressing the use phase of biocidal products, “because, in fact, industry knows how its products are labelled and, therefore, how they are supposed to be used. Even if surveys suggest we know little about it!”

 

The use of biocides is often by consumers, often in domestic and urban areas and “sensitive areas” such as hospitals and schools, Adams argued at the Fresenius Conference.

 

Many biocides are freely available to amateur users in supermarkets a few metres from fruit and vegetables, toilet rolls and shoe polish. How much more information is needed for such products?

 

Currently, training schemes for professionals tend to be specific to product types – any new legislation should recognise this, Adams emphasized: “One size does not fit all! We do not need to re-invent the wheel, but we need to harmonise and recognise minimum standards which require a legislative framework and implementation.”

 

He made a case for a Sustainable Use Directive for Biocides and said that the building blocks already exist.

 

The complete Fresenius conference documentation including scripts from all the presentations can be purchased at the Akademie Fresenius for €295 (plus VAT).