Interview: “Authorities often can’t see beyond the risks of using biocides”
The outcome is conservation of both natural and financial resources, which are thus available for other purposes in society. On the other hand, the aim of the strategy cannot be to combat all microorganisms equally and per se, but rather only where they cause damage – to ensure the environment suffers as little as possible, stresses Dr. Frank Sauer, author the book “Microbicides In Coatings“.
What is the current focus of R&D work in the field of biocides?
Dr. Frank Sauer: “It takes vast amounts of money and several years of work to bring new biocides to market. Before a biocidal product containing a new active substance can be marketed in the EU, the active substance must first undergo a complex registration procedure. Once the active substance has been approved, any biocidal products based thereon must then also be authorised. It is therefore not surprising that very few new active substances are being developed. Instead, the industry has opted for a strategy of skilfully combining different active substances in such a way that the weaknesses of one are compensated for by the strengths of the other.
How much regional variation is there in the use of biocides worldwide?
Sauer: The approval procedure for biocides under the EU Biocidal Products Regulation (BPR) is basically comparable to that in the USA, but is not identical: active substances and products based thereon go through a multi-stage registration process. In other regions of the world, such as Asia and South America, the procedure for authorising such products can vary considerably. In some countries all that may be needed is to have the active substance listed in a national inventory, whereas in other countries a dossier must also be submitted. In the latter case, however, the documents to be provided often have to meet very different official stipulations. Again, there has been a trend in recent years whereby, for example, some countries in Asia are implementing their own biocidal legislation which draws extensively on European legislation. One example is the draft of the so-called “K-BPR” in Korea, a registration procedure similar to the BPR in the EU. Korea already has already legislated its chemicals sector with a process that is very similar to REACH.
Dr. Frank Sauer
How is the situation in China and India?
Sauer: The situation in China is somewhat more complex. In theory, chemical products can be marketed there if all the ingredients are listed in the national chemicals inventory. However, exemptions apply to certain applications, such as rodenticides and wood preservatives. In these cases, data packages also have to be submitted and the registration is then performed by the authority responsible for that area of application. India, for its part, currently has no regulations that expressly focus on biocidal products. But it does have legacy legislation governing the use of pesticides and insecticides. The authorities have opted to apply it to biocidal active substances, even though this is a totally different usage case altogether. It might thus become necessary to submit studies that would only be needed for plant protection products in the EU.
In India, they are currently drawing up new legal requirements governing the use of biocides specifically in paints and coatings, and new stipulations on the use of such active substances. However, this is a very lengthy process and it is not yet clear when this set of regulations will come into force. In the meantime, established procedures will continue to apply.
What are the results of regulations on the use of biocide products?
Sauer: The purpose of biocidal agents is to kill microorganisms or to inhibit their growth. Naturally, a class of compounds such as this can also pose a certain risk, since they – like many other chemicals – can impact humans and the environment. However, this aspect is extensively tested during the approval procedure, so that it can be assumed that approved active substances and authorised products are safe wherever there is compliance with the legal requirements. Certain classes of substance, such as those with highly sensitising properties, and CMR substances (carcinogenic, mutagenic, toxic for reproduction) come in for particular scrutiny by the authorities and the barriers to approval there are consequently very high. The European Biocidal Products Regulation stipulates that CMR substances will not normally be authorised unless certain criteria justify an exemption. This is the case where the risk to humans, animals or the environment is negligible under realistic worst-case conditions of use, where it is demonstrated that the active substance is absolutely necessary to prevent or control a serious risk to human or animal health or to the environment, or where the non-approval of the active substance would have disproportionate adverse effects on society, compared with the risk to human or animal health or the environment. However, even if such a derogation is granted, this substance is still deemed to be a candidate for substitution and, every time the approval comes up for renewal, a check will be made to see whether a less dangerous alternative exists. In such a case, an existing approval would not be renewed.
Your book “Microbicides in Coatings” was published last summer.What can readers expect?
Sauer: The book is intended to provide an overview of everything that matters concerning the use of biocides in paints and coatings. This subject area is highly complex and the available literature is extremely extensive. The main difficulty lay in distilling the essential elements without getting lost in the detail. A further goal was to provide specific groups of people, such as paint manufacturers, formulators and researchers, with key information to help them in their daily work. An extensive bibliography has been included for those readers seeking further information on a particular topic.
The book starts with an overview of the fascinating world of microorganisms and goes on to discuss the properties of biocidal active substances and their use in the field of paints and coatings. It then deals with application aspects and test methods in this sector, following this with an overview of technological trends, including some new developments, before concluding with a discourse on regulatory topics.
What were further reasons for you to write the book?
Sauer: The book also aims to draw together the various strands of the public’s perception of biocides and to compare the benefits and risks of this class of compounds as objectively as possible. After all, there are plenty of everyday objects, such as a hammer, which can be dangerous to people and the environment if they are misused or abused. Every danger has an associated risk, i.e. there are circumstances in which a theoretical danger becomes a real one. A lion in the wild is potentially very dangerous and the risk to individuals is high. A lion behind bars in a zoo is just as dangerous, but the risk of being eaten there is relatively low.
“Microbicides In Coatings” gives an overview of the use of biocides in the protection of materials, including the relevant official regulations.