What are the consequences for the industry of the European Biocide Directive?
May 2007
By Johanna Wahlqvist
The European Biocide Directive (EBD) is now in its third phase of implementation. A person with regulatory affairs responsibility in the pulp and paper industry must understand what this means for the application of products for microbiological growth control, as any product used for this application is covered by the directive.
In 1993, the European Commission initiated the establishment of a harmonized authorization system for biocidal products in all member states. Five years later this resulted in the EBD, published in April 1998. The main objective of the new legislation has been to harmonize the internal European market and at the same time provide a high level of safety in use for humans, animals and the environment.
The definition given in the EBD is broad, to say the least. It states that a biocide is defined as "Active substance and preparation, containing one or more active substances, [...] intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
This means a chemical product by this definition very well can be a biocide without eliminating or even reducing the number of harmful organisms. Instinctively this may seem like a contradiction, and consequently it covers products where the biocidal properties are not obvious.
There is a guideline about what should be considered a chemical mode of action. This reads: "A substance controlling harmful organisms is regarded as an active substance acting by chemical means when the control is linked to the interference of that substance in biochemical/physiological processes through direct chemical interaction (inside or outside the target organisms) or indirect modifications because of the physical/chemical properties of the substance (chemical means)."
In the same document there is a reference that in case of doubt it is up to the applicant to justify that the acting mechanism is exclusively non-chemical and non-biological. If the supplier cannot do this, the substance will be considered a biocide and shall be covered by the EBD.
A number of examples have been reviewed to define further what constitutes a biocide by the new definition. One example is a case where a cleaning product intended to inhibit the adhesion of fouling organisms onto surfaces under water was marketed as having no biocidal effects. The producer explained that instead of destroying the organism, its product worked by hydrolyzing the cement that the organism secretes from glands to attach itself to a surface. The organism was not killed, but simply moved away and chose another surface not treated with the product. This explanation was not accepted, referring to the statement that any controlling effect on the unwanted organisms' action is enough to make a product a biocide. It is clearly not necessary to have a damaging effect.
Even though the possibilities are small to interpret the law in favor of a non-biocidal claim, there have been some interesting borderline cases where the producer succeeded, quite often by claiming that its product acts by physical means, not chemical or biological. This can be exemplified by a claim made by the wood preserving industry. In order to preserve wood, crude tall oil is used to prevent the growth of wood-decaying fungi. The tall oil works mainly by preventing the entry of water into the wood. After numerous discussions, this was considered to be a physical action. The product does not fall under the biocide directive. However, what is beyond doubt is that it is the mode of action of the active substance, and not the line of argumentation from the supplier, that decides whether a substance falls under the EBD. Most claims of this type have been declined.
Coverage and implementation
The full list of notified biocides can be found in the Commission Regulation 1048/2005 Annex II available on the ECB website (http://ec.europa.eu/environment/biocides). To date, only one substance has gone through the approval process, but this list will be completed gradually as more substances are reviewed.
After the EBD came into force on May 14, 2000, EU Member States were given a transitional period during which they could continue applying their national laws. The full effect of the EBD will not be apparent till 2010.
The complex implementation of the EBD can be defined as a process in three phases:
- First phase: In this phase, producers and formulators were obliged to either identify or notify all existing active substances to the European Chemicals Bureau before March 28, 2002. Most of the suppliers of so-called biodispersants used in the pulp and paper industry have not notified their products. However, as an exception to this BIM Kemi notified the active substance of its range of Bimogard products.
The notified active substances were allocated into one or several of 23 different product types (functional categories). A substance can only be used in the product type(s) for which it is approved. An approved slimicide, for example, cannot automatically be used as an in-can preservative since these are two different functions.
In order to get a substance approved, the applicant was requested to send in extensive documentation concerning the risks for human health and environment associated with the substance. Respective responsible national environmental bureaux would review these documents.
- Second phase: In 2003, the Commission published the regulation document that was the result of the first phase: The Second Review Regulation. This included a list of all existing identified active substances, a list containing all identified and notified active substances together with the product types they are notified for, and a list with all existing substances for which no notification has been made, or in which no Member State has shown an interest.
The latest date after which a non-notified substance could be sold in all countries of the European Union was set at September 1, 2006. As an exception, Sweden allowed the sale of non-notified products until March 14, 2010.
- Third phase: During the third and final phase (beginning September 1, 2006) only notified substances, those included in Annex II, are allowed on the European market. When all dossiers have been reviewed and the calendar reads March 14, 2010, the EBD implementation process will be finished and only notified and approved substances will be available to the European pulp and paper industry. After this date, any producer that wants to sell a new substance as a biocide will have to start a new application procedure in order to get an approval. This is estimated to take approximately two years.
The present list in Annex II containing all notified substances must not be confused with the future list of approved substances. Results from substances for which the deadline to submit necessary documentation has been passed are showing interesting numbers. For anti-fouling products by way of example, 46 chemical substances were notified but documentation was sent in for only 10 substances. This highlights the need to understand that not all substances in Annex II will be available in the future.
What the industry must do
The product types used in the pulp and paper industry for microbiological growth control are among those that will be reviewed last for the EBD. For this industry segment there will be continuing uncertainty regarding which products can be safely supplied in the future and which products will disappear. A pulp or paper producer can prepare by:
- Asking its supplier of microbiological growth control program, whether biocidal or non-biocidal, to certify that its products are both notified and that the notification is supported by a full data file
- Checking the list of notified substances, as this is being gradually extended with additions of reviewed and approved substances
- Asking for proof if a supplier argues that a particular product for microbiological control is exempt from the EBD.
Johanna Wahlqvist is with BIM Kemi AB
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