technical guidance documents - Institute for Health and Consumer ...

RISK CARACTERISATION
A specific risk characterisation is made for secondary poisoning. PECoral and PNECoral are
calculated according to the procedures described in Section 3.8, either by using the available
BCF values or by calculation of BCF from the octanol/water partition coefficient. Both the local
and the regional PECwater are used to calculate PECoral.
5.4 RISK CHARACTERISATION FOR NEW SUBSTANCES
The risk characterisation in the context of article 5 of and Annex III to Directive 93/67 also
involves the iterative revision of the PEC/PNEC ratio as a function of the degree of risk
predicted. In addition, a link is made with the tonnage triggers for further testing as laid down in
Article 7.2 of Directive 67/548. If the PEC/PNEC ratio is found to be less than or equal to one,
the conclusion laid down in Article 3(4)(i) of the Directive shall apply:
• the substance is of no immediate concern and need not to be considered again until further
information is made available in accordance with Articles 7(2), 8(3), 8(4) or 14(1) of the
parent Directive 67/548.
If the PEC/PNEC ratio is greater than one, the authority should judge which of the conclusions
set out in Article 3.4(ii), 3.4(iii) or 3.4(iv) that shall apply:
• the substance is of concern and the competent authorities shall decide what further
information is required for revision of the assessment but shall defer a request for that
information until the quantity placed on the market reaches the next tonnage threshold as
indicated in Article 7(2), 8(3) or 8(4) of Directive 67/548;
• the substance is of concern and further information shall be requested immediately;
• the substance is of concern and the competent authority shall immediately make
recommendations for risk reduction.
In the light of rather extensive experience of testing and evaluation procedures linked with the
aquatic environment, it has been possible to develop a relatively structured decision scheme in
relation to the aquatic compartment. This scheme is given in Figure 18.
It is assumed that for substances entering the scheme, data equivalent to those foreseen in Annex
VII A (the base set) to Directive 67/548 will be available. Information contained in the base set
is used to estimate the PEC and the PNEC for the aquatic environment. Furthermore, the
assumption is made in the decision scheme that where the PEC/PNEC ratio exceeds one, the
authority has discussed this situation with the notifier and that the values, in particular the PEC,
have already been amended in the light of further information provided by the notifier. The first
PEC/PNEC ratio referred to in Figure 18 is therefore the value as amended after further
discussions with the notifier.
Depending on the value of the PEC/PNEC ratio, one of the options available under article 3.4 of
Directive 93/67 is chosen. Where the PEC/PNEC ratio is between 10 and 100, the decision
whether to request further testing immediately or at the 10 tonnes per annum production level
will be made on the basis of a number of factors including:
1. indications of bioaccumulation potential;
2. the shape of the toxicity/time curve in ecotoxicity testing;
3. data on structurally analogous substances.
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