Until recently, the advertisement, sale, supply, storage and use of all pesticides was regulated in the UK by the 1986 Control Of Pesticides Regulations. These are gradually being replaced as pesticide legislation is harmonised across Europe under the twin directives, 91/414/EEC and 98/8/EC. Each directive focuses on pesticide active ingredients with specific areas of use.
Agricultural pesticides (or ‘plant protection products’) are covered by the Agricultural Pesticides Directive (91/414/EEC). This is being implemented in the UK under the Plant Protection Products Regulations 1995 (PPPR) and responsibility for transposing it into UK law lies with the Pesticide Safety Directorate (PSD). It applies to all pesticides used outdoors on plants, whether for agricultural, amenity or amateur use.
Non-agricultural pesticides (or ‘biocides’) now come under the Biocidal Products Directive (BPD)(98/8/EC). This is being implemented in the UK by the Biocidal Product Regulations (2001) with the Health and Safety Executive (HSE) as the lead agency, or ‘Competent Authority’. The scope of BPD is much wider than that of 91/414/EEC. It covers 23 different product types including disinfectants, preserving chemicals, anti-fouling treatments, water biocides, rodenticides, and timber treatment products. It includes substances not previously covered under pesticide regulations such as disinfectants, but will not include substances covered under other European Community legislation such as agricultural pesticides, medicines and cosmetics.
BPD (98/8/EEC) came into force on 13 May 2000. From 14 May 2000 new active ingredients had to meet the criteria it sets out (however no new biocides have come to market in the four years that have elapsed since!) while those already on the market are now being reviewed. This review process is expected to take about 10 years.
The procedures required under BPD for reviewing active ingredients are very similar to those required under the agricultural pesticide directive. There will be a period while member states make the transition from national pesticide legislation to regulation under BPD. Procedures for regular evaluation of progress during this transition period are described within two Review Regulations of the European Commission. The First Review Regulation (EC 1896/2000) describes the process for ‘identification’ and ‘notification’ of active ingredients. Manufacturers not intending to submit dossiers of health and safety data to support their products through review can ‘identify’ their products. Manufacturers intending to submit a supporting dossier need to ‘notify’ their intention to put their product forward for review. Identifications and notifications had to be submitted to the European Chemical Bureau (ECB) by 28 March 2002. Substances which are only identified are placed on annex 2 of the directive. These can remain on sale until 1 September 2006. Sale of products which has neither been identifed or notified became illegal from 14 December 2003.
The review of notified biocides will be based on their potential risks rather than on the inherent hazards of the chemicals. This process is to be carried out in several stages and biocides passing the review will be placed on annex I, IA or IB indicating that they can be marketed in member states. The Second Review Regulation (2032/2003/EC) lists the product types to be reviewed in order of priority. Biocides used in rodenticides and timber treatment products are being reviewed first as they are particularly hazardous. The lists of products whose biocidal active ingredients are to be reviewed at each stage can be seen in the table below.
The process of reviewing dossiers will be shared by the different EU member states. Once member states receive dossiers they have 90 days to ensure it is complete and a further year to review it. The member state responsible for review will make a recommendation on inclusion or non-inclusion on annex 1, and the decision then goes to a vote.
Many products not supported
The first impacts of the biocides review are starting to become apparent with deadlines for identification and notification now passed. The European Chemicals Bureau received 553 notifications (representing 372 actives) and 2,700 identifications (representing 759 actives). The total number identified and/or notified was 896 (some were both identified and
notified)(1). This means that out of 896 biocide active ingredients on the market in 2000, 524 will no longer be sold after 1 September 2006 leaving only 372 on the market at this time.
Of the 372 biocides notified for review, 96 are rodenticides or timber treatment biocides due to be reviewed in stage 1. The UK’s Health and Safety Executive were allocated 11 of these for review. However, the deadline for submission of dossiers passed on 28 March 2004 and only two were received (those for dichlofluanid and guazatine triacetate). EU-wide out of the 96 dossiers expected, only 45 were received.
The lack of support for biocide active ingredients is dramatic. Although the review process has only started it seems that the percentage of unsupported actives is significantly higher than for agricultural pesticides. The reason for this may be two-fold. Firstly, the agricultural pesticide market has become extremely concentrated in the past decade with few agrochemical companies now controlling the majority of the market and having access to the substantial capital required to carry out health and safety testing. The market for biocides has not undergone such concentration and so companies may have access to much less capital. Secondly, biocide markets may often be smaller than those for agricultural chemicals, making financial investment in these products less lucrative. There are likely to be significant changes in the market over the years to come. Companies successfully taking products through the review process may have access to significantly expanded markets as competing products drop out. It is also possible that some biocides are not being supported as manufacturing companies are aware they would not meet the set criteria.
There are a number of interesting differences between 91/414/EEC and 98/8/EC. Firstly, the principle of comparative assessment and substitution is enshrined in the biocide review process. This means that a more risky pesticide may not be licensed where safer products exist. In practice all biocides passing review will be placed on annex 1. At a later date, different biocides licensed for the same use will be compared and, in theory, the more risky ones removed from the market.
Secondly, while BPD seeks to protect human health and the environment it is primarily concerned with unifying the European market. Consequently, the directive only covers products supplied to others. Biocides made but not sold are not covered. Hence, any companies making biocidal products solely for their own use will be unaffected by this legislation. This is distinct from 91/414/EEC which covers all manufactured agricultural pesticides.
The review process being carried out under BPD should in theory increase standards of health and safety within the biocidal products market. In the past biocides were often developed for markets which were initially small and testing was incomplete. Profits from successful marketing allowed additional testing and subsequent expansion of markets. It should no longer be possible to place products on the market which have not met criteria specified within BPD. However, with manufacturers decisions dominated by profitability it remains to be seen whether those products remaining on the market are the safest.
| Review Lists | Pesticides for Review | Date for Dossier Submission |
| List 1 | wood preservatives (8), rodenticides (14) | 28 March 2004 |
| List 2 | insecticides and acaricides (18), repellents and attractants (19), molluscicides (16), antifoulings (21) | 30 April 2006 |
| List 3 | human hygiene biocides (1), veterinary hygiene biocides (3), private and public health care biocides (2), feed and food disinfectants (4), drinking water disinfectants (5) metalworking fluid preservatives (13) in-can preservatives (6) | 31 July 2007 |
| List 4 | preservatives for films (7), fibre, rubber and polymerised material preservatives (9), masonry preservatives (10), food/feed preservatives (20), liquid cooling/processing systems preservatives (11), embalming and taxidermy fluids (22), slimicides (12), avicides (15), piscicides (17), other vertebrate control (23) | 31 October 2008 |
| The European Commission assigns each product type a number indicated in the brackets. | ||
1. Three pesticides licensed under the UK’s Control of Pesticide Regulations were not identified by manufacturers. It is not known how many additional pesticide active ingredients were not identified.
[This article first appeared in Pesticides News No. 65, September 2004, page 16]