The proposed ‘Community [Union] Directive concerning the placing of biocidal products on the market’ (No. 93/C 239/03), or Biocidal Product Directive (BPD), has been in draft form for nearly three years and was published in the Official Journal of the European Communities [now European Union(EU)] last September(1). It is extensively modelled on the Plant Protection Products Directive (91/414/EEC) which regulates agricultural pesticides. The main aims of the BPD are to standardise the way in which biocides are regulated throughout the EU; to eliminate trade barriers for biocides throughout the EU; and to ensure that health and the environment are protected from the hazards presented by these products.
The broad scope of biocides
The term ‘biocides’ has been adopted in place of
‘non-agricultural pesticides’ to facilitate inclusion of a huge diversity of
products which have not previously been classed as pesticides. As well as more
traditional pesticides such as insecticides, rodenticides, acaricides,
fungicides, and preservatives of masonry and wood the term now includes
industrial and domestic biocides such as air-conditioning biocides, sanitary
biocides and other specialist biocides; disinfectants including those used in
swimming pools, the food industry and in homes; and preservatives including
textile and consumer product preservatives, though not food preservatives.
As a result of this expansion in the scope of chemicals
destined to be controlled by the BPD, sectors of the chemical industry which
have never had to deal with the rigours of product registration have joined
forces with the ‘old soldiers’ of the pesticide industry in tentatively
welcoming, while simultaneously trying to limit the requirements of the
Directive.
Industry is dissatisfied
In an industry position paper produced by CEFIC(2)
recently identified a number of concerns about the BPD. These included excessive
data requirements for some products, inadequate data protection allowances and a
clear dislike for ‘comparative assessment’ which is a clause which aims to
prevent the use of an active ingredient in biocidal products where an equivalent
safer ingredient exists. The position paper also points to inadequacies in the
transitional arrangements and common principles for the BPD which are not yet
finalised, and which CEFIC feels would benefit from significant input from
industry. Industry clearly welcomes the removal of trade barriers by harmonising
the registration requirements for biocides in all EU Member States, and by
requiring that products approved in one State be approved in all other Member
States where an application is made.
NGOs like BPD in principle
A paper produced by a loose coalition of NGOs
concerned with health and safety and environmental issues late in 1992(3)
identified ten key issues which were considered to require amendment. Not
surprisingly many of the issues identified were the same as those which concern
industry, but the views expressed by the NGO group were in direct opposition to
those of industry. The NGOs for example, welcomed the ‘comparative
assessment’ clause and sought to give it “greater prominence as a
fundamental principle of the Directive”. Similarly while industry sought to
protect data submitted for registration purposes for as long as possible, the
NGOs called for data to be shared and made publicly available.
Who does what in Europe
Belgium: the Ministry of Public Health
and Environment regulates biocides in a separate system from agrochemicals. both
systems are funded by registration fees. The scope of the system is wider than
in the UK and efficacy of the product is deemed to be of high importance.
Industry complains that the Belgian system is very slow.
Denmark: the Environmental Protection Agency runs an approval
system for non-agricultural pesticides in parallel to the agricultural pesticide
approval system. Both systems are funded by taxes on product sales. Denmark
wants the broader scope of chemicals to be covered by the BPD. Their current
approval system takes a minimalist approach to the efficacy of products and
places great importance on environmental controls.
France: There is currently no systematic approval system for
non-agricultural pesticides or biocides. The Environment Ministry appears to
welcome the proposed BPD, but the Industry Ministry has reservations about it.
Germany: Currently has no approval system for biocides and is keen to
adopt the BPD with its proposed scope of products, though they might support
phased introduction with certain conditions. The German Environment Ministry
supports comparative assessment, and in general the German authorities appear to
want rigorous controls on biocides.
Ireland: the Irish Ministry of Agriculture Forestry and Food run an
approval system for non-agricultural pesticides which is part funded by
registration fees. They appear to take a similar line to UK officials who would
prefer to see the scope of the BPD reduced in order to use limited resources
more effectively in the control of the most hazardous products.
Netherlands: The existing approval system is similar to the BPD and
the Netherlands is the only nation likely to have to lower their standards when
the BPD is adopted. Unlike the UK, the Dutch authorities do not consult with
industry at all, and have been challenged in the courts by companies. They have
high data requirements and apparently tend to treat data protection loosely.
Important elements of product evaluation are efficacy and risk assessment.
UK: The Health and Safety Executive (HSE) runs an approval system
for non-agricultural pesticides in parallel to the system for agricultural
pesticides which is run by the Ministry of Agriculture Fisheries and Food (MAFF).
The HSE is leading the UK response to the BPD. Like industry, the HSE believes
that the scope of the BPD is too broad, and does not adequately reflect the very
different circumstances in which some biocides are used and the relative hazards
posed by different chemicals covered by the BPD.
The HSE is keen that the requirements for registration of
biocidal products and the controls placed on them are commensurate with the
risks they present. This means that products which are deemed, by an initial
risk assessment, to be of relatively low risk will need less test data and be
subject to fewer controls than more hazardous products. This approach somewhat
contradicts the more precautionary approach currently taken by the Directive.
Seeking workable options
The HSE and British industry have conceded that the
scope of the BPD is unlikely to be reduced since there is little support from
other Member States. The next option is to press for a phased introduction of
the categories covered by the Directive with products which are currently
covered by existing National controls first and disinfectants and preservatives
last.
A close eye is also being kept on the Plant Protection
Products Directive as it is implemented. Where it fails, it is likely that the
UK will use the failure as leverage to press for what they feel will be a more
workable system in the BPD. (MD)