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GENERAL INTRODUCTION
product type. The common core data requirements in Annex IIA together with the specific data
requirements in Annex IIIA constitute a complete set of data, adequate as a basis for risk
assessment.
Due to the wide scope of the Biocidal Products Directive and the extensive variation of exposure
and risks of different biocidal product types, the general rules given in the Directive and its
Annexes have to be specified in order to ensure efficient and harmonised day-to-day
implementation of the Directive. As written in Article 33, the Commission, in accordance with
the procedure laid down in Article 28(2), shall draw up technical notes for guidance to facilitate
the day-to-day implementation of this Directive.
Technical Notes for Guidance on data requirements for active substances and biocidal products
(TNsG on Data Requirements, 2000; http://ecb.jrc.it/biocides/) give detailed practical guidance
on choice of studies and data reporting when applying for authorisation according to Directive
98/8. It should be noted that only chemical biocidal products and substances are covered.
Specific guidance is given on data requirements for substances of concern and in respect to
simplified procedures, i.e. those concerning frame-formulations, low-risk biocidal products and
basic substances.
Environmental exposure assessment is based on representative measured data and/or model
calculations. If appropriate, available information on substances with analogous use and
exposure patterns or analogous properties is taken into account. The availability of
representative and reliable measured data and/or the amount and detail of the information
necessary to derive realistic exposure levels by modelling, in particular at later stages in the lifecycle
of a substance, will also vary. Again, expert judgement is needed.
In order to ensure that the predicted environmental concentrations are realistic, all available
exposure-related information on the substance should be used. When detailed information on the
use patterns, release into the environment and elimination, including information on the
downstream uses of the substance is provided, the exposure assessment will be more realistic. A
general rule for predicting the environmental concentration is that the best and most realistic
information available should be given preference. However, it may often be useful to initially
conduct an exposure assessment based on worst-case assumptions, and using default values
when model calculations are applied. Such an approach can also be used in the absence of
sufficiently detailed data. If the outcome of the risk characterisation based on worst-case
assumptions for the exposure is that the substance is not “of concern”, the risk assessment for
that substance can be stopped with regard to the compartment considered. If, in contrast, the
outcome is that a substance is “of concern”, the assessment must, if possible, be refined using a
more realistic exposure prediction.
The guidance has been developed mainly from the experience gained on individual organic
substances. This implies that the risk assessment procedures described cannot always be applied
without modifications to certain groups of substances, such as inorganic substances and metals.
The methodologies that may be applied to assess the risks of metals and metal compounds,
petroleum substances and ionisable substances are specifically addressed in appendices to this
guidance document (Appendix VIII, IX and XI, respectively). In these appendices, it is indicated
as much as possible where the text of the main document applies and where not. Where
necessary, specific methods are described.
The risk assessments that have to be carried out according to Regulations 793/93 and 1488/94
for existing substances, Directives 67/548 and 93/67 for new substances and Directive 98/8 for
active substances and substances of concern in a biocidal product, are in principle valid for all
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