PA&MRFG-SoCWG-Doc04
Substances of Concern – Proposed Draft UK Position for Biocidal Products
(PA&MRFG-Feb12-Doc.6c)
1. Introduction
Annex VI of 98/8/EC or the Biocidal products Directive (BPD) lays down the
common principles for the evaluation of dossiers for biocidal products. The following
is stated at points 2, 3, 4, 5 & 7 of Annex VI of the BPD:
2. In order to ensure a high and harmonised level of protection of human and
animal health and of the environment, any risks arising from the use of a
biocidal product shall be identified. To achieve this a risk assessment shall be
carried out to determine the acceptability or otherwise of any risks identified
during the proposed normal use of the biocidal product. This is done by
carrying out an assessment of the risks associated with the relevant individual
components of the biocidal product.
3. A risk assessment on the active substance or substances present in the
biocidal product is always required. This will already have been carried out for
the purpose of Annexes I, IA or IB. This risk assessment shall entail hazard
identification, and, as appropriate, dose (concentration) - response (effect)
assessment, exposure assessment and risk characterisation. Where a
quantitative risk assessment cannot be made a qualitative assessment shall be
produced.
4. Additional risk assessments shall be carried out, in the same manner as
described above, on any other substance of concern present in the biocidal
product where relevant for the use of the biocidal product.
5. In order to carry out a risk assessment data are required. These data are
detailed in Annexes II, III and IV and, recognising that there are a wide variety
of product types, are flexible according to the product type and associated risks.
The data required shall be the minimum necessary to carry out an appropriate
risk assessment. Member States should take due consideration of the
requirements of Articles 12 and 13 of this Directive in order to avoid
duplication of data submissions. The minimum set of data required for an active
substance in any biocidal product type, however, shall be that detailed in Annex
VIIA to Directive 67/548/EEC; these data will already have been submitted and
assessed as part of the risk assessment required for entry of the active substance
into Annex I, IA or IB to this Directive. Data may also be required on a
substance of concern present in a biocidal product.
7. When making evaluations and taking decisions concerning the authorisation
of a biocidal product the Member State shall:
(a) take into consideration other relevant technical or scientific information
which is reasonably available to them with regard to the properties of the
biocidal product, its components, metabolites, or residues;
(b) evaluate, where relevant, justifications submitted by the applicant for not
supplying certain data.
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A substance of concern (SoC) is defined in Art 2 of the BPD as follows:
(e)
Substance of concern. Any substance, other than the active
substance, which has an inherent capacity to cause an adverse effect on
humans, animals or the environment and is present or is produced in a
biocidal product in sufficient concentration to create such an effect. Such
a substance, unless there are other grounds for concern, would be
normally a substance classified as dangerous according to Council
Directive 67/548/EEC of 27 June 1967 on the approximation of laws,
regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances (1), and present in the
biocidal product at a concentration leading the product to be regarded as
dangerous within the meaning of Article 3 of Council Directive
88/379/EEC of 7 June 1988 on the approximation of the laws,
regulations and administrative provisions of the Member States relating
to the classification, packaging and labelling of dangerous preparations
(2) (Amended by Directive 99/45/EC).
Further, at the PA&MRFG in December 2010 the following principle confirming
which SoCs would require risk assessment was agreed for subsequent circulation to
industry and incorporation into the Evaluation Manual:
‘A product only is considered to contain substances of concern when
those formulants are present at a concentration leading the product to be
regarded as dangerous.
The applicant is required to provide the concentration limits of any
formulant that is labelled for its intrinsic properties in the table for the
full composition of the product, thus providing the information as to
whether the formulant is a substance of concern in this product.
He only has to provide the dossier on the formulant, if the concentration
limits are exceeded (PA&MRFG-Dec-Doc3a).’
It was recognised by the PA&MRFG in December 2010 that there was a need for a
harmonised approach regarding the data required to assess an SoC. However, at that stage,
there were insufficient resources to do this.
During our assessment of BPD product evaluations in the UK, we have been looking to
produce general guidance for applicants on the performance of appropriate risk
assessments for SoCs in UK product applications, which we are now able to share with MS
as a thought-starter in the possible production of an MS harmonised approach.
2. Data requirements for formulants, recognised as substances of concern
The BPD requires that a risk assessment is performed for all active substances and
SoCs in a biocidal product. The TNsG for data requirements states in Section 4.2 –
titled ‘What are Substances of Concern?’ that:
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‘It is always primarily the applicant who must identify all possible
substances of concern in the product and submit the basic data for risk
characterisation (Art 8(6) in Directive).’
In addition, section 4.3 of the TNsG for data requirements – ‘Data requirements for
Substances of Concern’ states that:
‘A basic data set is required for the preliminary risk characterisation of
the identified substances of concern. It should be noted that study reports
need not be submitted, but all information submitted must include a
detailed description of the references and of the actual source of data.
Relevant sources include e.g.: databases, scientific publications,
handbooks and summaries collected and edited by scientific
organisations or authorities. Also data included in the Safety Data Sheet
of the substance can be used, however, the original reference should be
given as well. The general rules on data protection laid down in the
Biocidal Products Directive have to be respected; i.e. a letter of access
may in some cases be required.’
Clearly paragraph 4 of Annex VI of the BPD has an assumption that an active
substance type risk assessment should be carried out in the first instance for SoCs.
However the Directive text also contains several caveats. Point 3 of Annex VI of
98/8/EC indicates that qualitative rather than quantitative risk assessments may be
performed where a quantitative one cannot be produced, and the ‘where relevant’ part
of point 4 of Annex VI is important as it allows applicants to demonstrate that the risk
is likely to be acceptable with qualitative arguments or more simplistic calculations
(e.g. Tier I exposure assessment).
It should also be noted that as indicated in the text reproduced from the TNsG above
the onus is on applicants to identify SoCs and to provide appropriate information/data
for any identified, and an appropriate risk assessment if necessary.
The UK CA is of the view that to perform full risk assessments for every SoC in
every formulation is not only impractical, unworkable and unsustainable but also not
justified from a scientific point of view. A tiered approach is therefore required to
assess the risks posed by SoCs in a proportionate manner. Against this background,
the following assessment schemes for SoCs to address both the environment and
human health are proposed. As regards the physicochemical/analytical endpoints
some comments of the original position in the paper PA&MRFG-Dec10-Doc3a have
been provided in section 2.3 of this document.
2.1 Human Health
2.1.1 Substances of Concern – Proposed UK Toxicological Assessment Scheme
for Biocide Product Applications
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The human health scheme takes into account the nature and severity of the hazard
classification of the SoC, the concentration/percentage of the SoC in the formulation,
the relative toxicity of the SoC compared to that of the active substance and the
relative ratio between the active substance concentration and the SoC concentration in
the formulation.
The proposal requires that a product is assigned to one of four possible hazard
classification bands. If a product can be assigned to more than one band, the
evaluation requirements of the higher band will apply.
Within each band, if the classification of the product is solely due to the presence of
one or more co-formulants/SoCs in the formulation (i.e. the co-formulant/SoC is more
“toxic” than the active substance), then an assessment of the relevant SoCs is
required. Obviously, if the classification of the product is solely due to the active
substance, then there is no SoC for the hazards assigned to that specific band, and no
SoC assessment is required. There could also be a situation where both the active
substance and a co-formulant/SoC contribute to the classification of the product. In
this instance, it is proposed that, on practical grounds, an assessment of the SoC is
required only when the concentration of the SoC in the formulation is higher than that
of the active substance. For co-formulants classified for the same hazards, which are
present in a product at concentrations insufficient for SoC considerations but that, in
combination, trigger the classification of the product, a case-by-case approach should
be taken.
It should not be forgotten that products classified as Toxic, Very Toxic or C
(Carcinogenic) M (Mutagenic) R (Toxic for Reproduction) Cat 1 or 2 under the
Dangerous Preparation Directive (DPD) cannot be used by the general public (Art
5(2) of the BPD), regardless of whether the classification is triggered by the active
substance or by one or more co-formulants/SoCs in the formulation.
The proposed scheme utilises the classification and labelling elements of the DPD.
When in 2015 the application to mixtures of the requirements of the CLP Regulation
(which amends and repeals the DPD) becomes obligatory, the equivalent
classification and labelling elements of the CLP Regulation should be taken into
account.
BAND A - Products classified for acute toxicity, irritation/corrosivity and/or
sensitisation with R20, R21, R22, R23, R24, R25, R65, R36, R37, R38, R41,
R34, R35 or R43 under the DPD, requiring the assessment of relevant SoCs.
Acute toxicity studies and/or irritation/sensitisation studies on the formulation (if
available) should be considered to verify whether the predicted hazard(s) (by the
calculation method of the DPD) are confirmed. If the predicted hazards are not
confirmed by the formulation test data, then the product is no longer classified for
acute toxicity/irritation/sensitisation and there is no need to perform a risk
assessment for the co-formulant/SoC which had initially raised the concern. If the
predicted hazards are confirmed, appropriate risk mitigation measures, in the form
of the safety phrases triggered by the relevant R-phrases, should be applied. It
should be noted that a full quantitative risk assessment is not usually performed
for acute toxicity or irritant/sensitising effects. If the relevant formulation studies
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are not performed, the predicted hazards should be treated in the same manner as
the confirmed hazards.
BAND B - Products classified with Repr Cat 3 (R62, R63), Carc Cat 3 (R40),
R48/20/21/22, R26, R27, R28 or R39 under the DPD, requiring the
assessment of relevant SoCs. It is proposed that a qualitative risk assessment is
performed. This should consider the potential for exposure to the SoC, by taking
into account the physical-chemical properties of the substance (e.g. dustiness,
volatility), the concentration of the substance in the formulation and the use
pattern of the product. If significant exposure cannot be excluded, appropriate risk
mitigation measures, in the form of the safety phrases triggered by the relevant Rphrases and additional measures, as appropriate, should be applied.
BAND C - Products classified with Repr Cat 1, Cat 2 (R60, R61),
R48/23/24/25 or R42 under the DPD, requiring the assessment of relevant
SoCs. It is proposed that a more quantitative risk assessment is required for the
relevant SoC. Wherever possible, no additional animal testing on the relevant SoC
should be performed simply for the purposes of establishing an AEL (Acceptable
Exposure Level) for the SoC within the scope of the BPD. Every effort should be
made by the applicant to avoid further vertebrate testing and to gain access to
available data/information. A reasonable assumption is that at least the data that
have triggered the classification of the relevant SoC should be accessible. If the
applicant is unable to obtain access to the available data, other evaluation options
should be discussed with the regulatory authority.
As it is most likely that the majority of the co-formulants used in biocidal products
fall within the scope of REACH registration, it is proposed that DNELs (Derived
No Effect Levels) stipulated within the Chemical Safety Assessment (CSA) are
used in place of AELs to streamline the evaluation process. The DNELs for a
specific substance can be retrieved from the dissemination website of ECHA, but
also from the extended SDS (Safety Data Sheet) of the substance. With regard to
the exposure assessment of the relevant SoC, if acceptable risks are identified at
tier I, a Tier II should not be performed.
BAND D - Products classified with Muta Cat 1, Cat 2, Cat 3 (R46, R68), Carc
Cat 1 or Cat 2 (R45, R49) under the DPD, requiring the assessment of
relevant SoCs. It is proposed that the use of such co-formulants/SoCs (i.e. coformulants classified with Muta Cat 1, Cat 2, Cat 3 (R46, R68), Carc Cat 1 or Cat
2 (R45, R49) in biocidal products should not be permitted in most instances as,
due to the inability to demonstrate with a confidence a threshold dose for these
hazards, unacceptable risks would be identified at any exposure level. The use of
such co-formulants/SoCs could be allowed only if no technically and
economically viable (safer) alternatives are available and the benefits brought
about by these substances outweigh the risks.
2.2 Environment
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The following assessment scheme for environmental assessments for SoCs in UK
biocidal product applications is designed to present a tiered scheme, which will
provide several options of increasing complexity (and requiring increasing resource to
perform) in order to allow an applicant to demonstrate an acceptable risk from their
SoC without necessarily being required to provide a full basic data package and
performing an active substance type risk assessment in every case when this is not
justified.
With regard to Screen Step 1 presented below, we are aware that there is a risk that in
some instances dilution of the formulation to a treatment solution may create a
situation where a full assessment based on submitted data is required for the biocidal
active substance, but that a SoC present in the formulation at a higher concentration
than the active substance may not require a risk assessment. Clearly in such a
situation there would be a disparity between the level of assessment performed for the
active substance and that performed for the SoC. However, the triggers for the
consideration of whether a co-formulant is considered a SoC are based on hazard and
concentration in the formulation, rather than risk based as they are for the active
substance. Where an applicant dilutes such a formulation and then sell in larger packs
in that diluted form, the co-formulant would never be considered a SoC and no
assessment of that co-formulant would be performed; yet ultimately the risk to the
environment from that co-formulant may be the same whether the formulation is sold
in neat or dilute form. Hence there may also be a disparity in the approach taken for a
neat and dilute formulation that may not be justified from an environmental risk
assessment perspective. It is worth additionally noting that in some cases the opposite
may apply, where for example a route of exposure may increase the concentration of
the SoC, it may be that the formulation concentration limits should be disregarded.
Clearly this could be quite complicated, and any submitted argumentation along these
lines should be considered on a case by case basis with particular consideration being
given to the use of the substance and consequent route of exposure.
In the majority of cases the toxicity of the formulation should be driven by the
biocidal active substance, therefore we consider that this is where the bulk of our
effort should be directed. We do not have the resource to perform full risk
assessments for every SoC in every formulation and such an approach would not be
justified in every case. The whole tiered approach is designed to assess the risk for
SoCs in a proportionate manner, and it is anticipated that Tier 4 risk assessments,
based on full data packages as required by the available TNsG on data requirements
guidance document, will only be performed for SoCs in rare instances where the risks
identified by the earlier tiers warrant such an approach.
2.2.1 Substances of Concern – Proposed UK Environmental Assessment Scheme
for Biocide Product Applications
The following tiered risk assessment scheme is presented to provide general guidance
to applicants for the performance of appropriate risk assessments for SoCs in UK
product applications, in order to address the risk to the environment from such
substances. The guidance is intended to provide methods of environmental assessment
for SoCs before the ecotoxicological data requirements outlined in chapter 4.3 of the
TNsG on data requirements, and subsequent detailed risk assessment, are required.
Applicants have to be aware that it is their responsibility to support any argumentation
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with the provision of appropriate information (e.g. material safety data sheet), data,
letters of access or calculations.
It is not anticipated that the guidance will address every situation, and where
applicants consider that their product type, proposed use, or SoC falls outside the
scope of this guidance document they are encouraged to contact the CA to discuss an
appropriate alternative approach prior to application.
2.2.2 Tiered Environmental Assessment Scheme for Substances of Concern
(SoC)
The following provides an overview of a tiered assessment scheme for the
environmental assessment of SoCs for UK product applications:
Screen step 1:
Screen step 2:
Tier 1:
Tier 2:
Tier 3:
Tier 4:
Is the SoC still a SoC for the proposed use for environmental risk
assessment (e.g. where the concentration in the product of the coformulant results in classification for the environment consider the
in-use concentrations of any environment formulation SoCs).
Qualitative arguments. (e.g. consider potential for rapid loss due to
dissipation processes such as volatilisation, ready biodegradability
etc).
Formulation ecotoxicity data
Using ecotoxicological end-point information for the SoC calculate
a chemical risk factor (CRF) and compare to that of the active
substance to determine relative risk of the SoC and the active
substance.
Risk assessment based on scaled PEC from undegraded active
substance concentration and ecotox end-point.
Provision of data according to the requirements in Section 4.3 of the
TNsG on data requirements, and subsequent risk assessment.
The above tiers are discussed in more detail in the following sections:
Screen step 1: The TNsG on Data Requirements indicates that one of the triggers for
consideration that a substance is a SoC is that the substance is included in Annex I of
Council Directive 67/548/EEC as amended by regulation 1272/2008 (the CLP
regulation) i.e. it is classified as dangerous; and its concentration in the product
exceeds the classification limit set in Council Directive 88/379/EEC, as amended by
Directive 1999/45/EEC1.
However, it is recognised by the UK CA that the environment will not be directly
exposed to some neat formulations. Where it can be demonstrated that for the
proposed use environmental compartments2 will only be exposed to the product in the
form of a diluted treatment solution and that the concentration of the co-formulants in
that treatment solution do not exceed the concentration levels indicated in the
Directives above, then it may be concluded that because of that dilution a SoC in the
formulation is not a SoC in the treatment solution, and no further environmental risk
assessment will be required.
1
It should be noted that other triggers for consideration of a co-formulant as a SoC exist, and the
approach is not likely to be successful in those cases.
2
Environmental compartments are: soil, surface water, sediment groundwater and air.
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Screen Step 2: It is possible that certain properties of the compound in question mean
that the environment is unlikely to be significantly exposed to the SoC. In such a
situation qualitative argumentation may be submitted by the Applicant to, in the
opinion of UK CA, unequivocally demonstrate that environmental exposure in a
particular compartment would be negligible. Such argumentation should be supported
by appropriate information. Examples may include very rapid degradation or
dissipation (e.g.by volatilisation and rapid photochemical oxidation in air).
Tier 1: At the first tier available formulation ecotoxicological data should be
considered in comparison to data for the active substance or substances. If this is
available and it is clear from those data that the active substance or substances drive
the risk assessment then it can considered that the risk from the SoC is addressed by
the active risk assessment3. However, it should be noted that data would be required
to be available on exactly the same organism as that for the active substance otherwise
a meaningful comparison could not be made. It is recognised that such data are
frequently not available; where this is the case then the Tier 2 approach could be
considered.
An example of a formulation comparison calculation is presented in Appendix 1.
Tier 2: Ecotoxicological, Fate and Behaviour and basic physico-chemical end-points
should be derived for the SoC based on available information (e.g. GLP laboratory
studies, material safety data sheets, EU or International chemical reviews, QSARs.
etc). It is the Applicants responsibility to make all reasonable efforts to source the
most up to date and reliable information and this should be detailed in the submission,
along with any letters of access that are required. Once data are obtained the relevant
end-points should be assessed and a PNEC derived which will include an assessment
factor in accordance with ecotoxicological guidance. In many cases (where for
example limited data are only available from MSDS or other publicly available
studies) that assessment factor is likely to be at least 1000. Consideration should then
be given to the relative concentrations in the formulation, and a chemical risk factor
(CRF) derived by dividing that formulation concentration by the PNEC for both the
SoC and active substance. A worked example for the CRF approach is presented in
Appendix 1.
Where the active substance risk assessment did not consider degradation and the CRF
is lower for the SoC than for the active substance, it can be concluded that the risk is
lower for the SoC than for the active substance and where an acceptable risk has been
demonstrated for an active substance an acceptable risk can also be concluded for the
SoC. Because ecotoxicological data are not readily available for organisms pertinent
to all environmental compartments for many general chemicals, where it is
demonstrated that sufficient efforts have been made by the applicant to locate relevant
3
It should be noted that because differences in transport and degradation processes for the SoC and the
active substance are not considered by the formulation ecotoxicological end-point or comparative CRF
approach, it is proposed that an assessment should be accompanied by a consideration of the exposure
of the SoC relative to the active substance for each environmental compartment. It is envisaged that
such a consideration would examine the phys/ chem. properties of both the SoC and the active
substance alongside the transport and dissipation processes that lead to the exposure of all individual
environmental compartments. Other approaches would be considered by the UK CA.
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data, the UK CA will accept the CRF approach as indicative of the general
comparative ecotoxicty of the SoC and the active substance. Therefore where, for
example, an acceptable risk is demonstrated using the CRF approach based on aquatic
ecotoxicity data alone, the conclusion drawn from that comparison may be considered
relevant to all other environmental compartments.
However, where the active substance risk assessment considered degradation and/ or
dissipation processes in order to demonstrate an acceptable risk, further consideration
of the SoC will be required4 for those environmental compartments where such
processes were considered for the active substance.
Tier 3: A final tier approach prior to the full data requirements and formal risk
assessment approaches outlined in the TNsG being triggered would be to calculate
simple PECs for the SoC and compare those PECs to an appropriate PNEC.
Calculation of the PEC would involve a linear extrapolation of the undegraded active
substance PECs for the relative concentrations of the SoC and the active(s) in the
formulation. In the absence of data, appropriate worst case assumptions regarding
exposure of the SoC to the different environmental compartments should be assumed,
and therefore the SoC PEC should be further corrected, again assuming a linear
extrapolation where appropriate, where the same worst case assumptions have not
been made for the active substance4. In addition corrections for the molecular weight
of the SoC and the active substance should also be made. If appropriate data are
available refinement could be made for degradation of the SoC, though it is
acknowledged that such data would often not be available in the first instance. As a
simple approach, where data are available that support the SoC being less persistent
than the active substance in the relevant environmental compartments (e.g. based on
results of hydrolysis studies or ready biodegradability tests), the linear PEC
conversion could make use of the degraded parent PEC as a refined approach at this
tier. Comparison of the PEC would be to an ecotoxicological end-point derived from
appropriate available data. In the absence of additional information at this tier, this
would be the same PNEC as derived at Tier 2.
A worked example for the scaled PEC approach is shown in Appendix 1. The
example only considers surface water, but all environmental compartments should be
considered in the submission in a similar manner.
Tier 4: Where the above screening steps and tiers do not indicate an acceptable risk to
all environmental compartments from a SoC, data are required to be provided
according to the requirements in Section 4.3 of the TNsG on data requirements for
those environmental compartments for which an acceptable risk has not been
demonstrated with lower tier assessments. A risk assessment utilising those data will
also be necessary to display an acceptable risk from the SoC. Depending on the
specific product type under consideration, additional product type specific data may
4
An example is for a PT8 wood preservative biocide product application; where a wood leaching study
has not been performed for the SoC a 100 % leaching loss from wood for the SoC in the assessment
period should be assumed. Where leaching data were available for the active substance and a leaching
percentage of < 100 % was displayed and used in the active substance exposure assessment, simple
linear correction from the active substance PEC to that for the SoC will be required to ensure the SoC
PEC is based on a conservative worst case assumption of 100% loss.
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also be triggered for the SoC in the same way that such additional data may be
triggered for the active substance.
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2.3 Physico-chemical properties and analytical methods
The following provides more detailed comments on the proposal of paper
PA&MRFG-Dec11-Doc5b as regards the physico-chemical properties and analytical
methods.
2.3.1 Physico-chemical data

If an SoC has been identified from a formulant in the product then the minimal
physico-chemical data requirements identified in the paper PA&MRFG-Dec11Doc5b to complete the environmental and human health risk assessments are
reasonable rather than requiring all the physico-chemical annex points to be
addressed as outlined in Directive 98/8.

When requesting data to complete a risk assessment there is a need to avoid being
unnecessarily burdensome on industry. Most of the physico-chemical data
referenced in the paper PA&MRFG-Dec11-Doc5b should be available on the
safety data sheets under the GHS (global harmonised system, implemented in the
EU under CLP – regulation No 1272/2008 for classification, packaging and
labelling). Whilst MS may be concerned about the reliability of using such data
compared to using data generated by the applicant and submitted for evaluation,
the UK CA view is that under CLP the data from the MSDS can be relied on as it
will be a requirement to provide information on how the physico-chemical
properties were generated i.e. test method, temperatures etc along with these data.
The only exceptions that are not specifically listed as being required on the safety
data sheets under CLP are the Henry’s law constant (however, this is a
calculation based on the vapour pressure and solubility in water which are both
required, and so the applicant/MS can always do the calculation) and the
dissociation constant. For the dissociation constant, if it is required, then reference
to reliable literature data (in which the purity tested and the test methods and
conditions used to generate the data are fully reported) can be made, or if the
supplier of the co-formulant can provide these data along with full details of the
purity tested and the test methods/conditions used then this would also be
acceptable. Only when there are no reliable sources of data should the applicant
be expected to generate the data required.
The only issue will be how these data are obtained during the transitional periods
before CLP is fully implemented in the EU. The MSDS at present may not
necessarily have all the physico-chemical data required or it may not be
sufficiently reliable to make use of it in a risk assessment (at present MSDS rarely
state the test methods used, the conditions and the purities tested). However, if the
supplier has these data, the test method/conditions used and the purity tested can
be supplied, then the data from the supplier is acceptable. Again literature data (if
it can be relied on as the purity tested and test method and conditions used are
reported) if available could be used. In some circumstances data may have to be
generated for the SoC by the applicant supporting the biocide product. This would
only be in very limited circumstances when there are no reliable data from any
other source.
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
To conclude no new data on the physico-chemical properties of SoCs should have to
be generated. The applicant for the biocide product should be able to reference data
provided on the MSDS or from the supplier or from the literature. Data would only
have to be generated where a specific concern on the reliability of the source of the
data is identified, e.g the test methods and conditions used and the purity tested are
not reported.
2.3.2 Analytical methods

In the TNsG it is stated that for the biocidal products analytical methods are
required for the determination of toxicological and ecotoxicologically relevant
components in the biocidal product and/or residues thereof. While these basic data
requirements should be applicable to SoCs arising from the formulants used in the
biocidal product the following must also be considered:
 If the level of the SoC is controlled in the formulant and the supplier has
specified this on the MSDS and has a method of analysis so the level in the
formulant can be determined, then the exact level of the SoC in the biocidal
product will be known. When the level of the SoC is clearly known in the
biocidal product at the point of manufacture and it cannot possibly increase
on manufacture or storage of the biocidal product, then analytical methods
and its determination on storage in the biocidal product should not be
required. Hence there should only be a need to fully validate a method of
analysis and determine the level of the SoC on storage in the biocidal
product, if there is the possibility that the level of the SoC will increase on
manufacture or storage of the biocidal product.
 With regards to analytical methods for residues of SoCs in the environment.
The need for such methods will be led by the environmental risk assessment.
However, it needs to be made clear upon evaluation of the SoC that having
post authorisation monitoring methods are necessary for the intended use
e.g. on consideration of likely dilution and hence exposure that will occur
for intended use. In addition, if the SoC in the environment may have several
sources and not just arise from a biocidal use then post authorisation
methods linked to monitoring biocidal use will be meaningless, hence such
methods should not be required for a biocidal authorisation.
UK CA for Biocides
February 2012
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Appendix 1 – Environmental assessment. Example Calculations for Tiered
Refinements
Tier 1: Example formulation comparison calculation
An active substance has been shown to have ecotoxicological end-point of 1.1 ug/ L.
The formulation for which an approval is being requested contains the active
substance at 10 % w/w and has an ecotoxicological end-point of 10 ug/L from a study
conducted with the same test species. As the active is present at 10 % w/w in the
formulation the equivalent active end-point derived from the formulation study equals
1 ug/ L (based on 10 ug/ L/ 10 %).
In the above example the active substance equivalent end-point calculated from the
formulation test is marginally lower than the end-point from the active substance test.
Because the active substance equivalent end-point from the formulation test is not
significantly higher (i.e. a difference greater than would be attributable to
experimental variability) than the end-point from the active substance test therefore
further investigation of any SoCs present in the formulation will be required.
Tier 2: Example calculations of Chemical Risk Factor (CRF) and comparative
assessment
A formulation contains an active substance and two co-formulants which have been
identified as SoCs. The active substance has been demonstrated to display an
acceptable risk by standard risk assessment methodology and without consideration of
degradation or dissipation processes. The end-points taken from SDS are
Table 1: End points in SDS for SoC1
Organism
Fish
Bacteria
Algae
End point
(LC50) mg /L
0.5-1.0
13
15
AF
PNEC
1000
-
0.0005
-
Table 2: End points in SDS for SoC2
Organism
Fish
Bacteria
Algae
End point
(LC50) mg /L
10
18
12
AF
PNEC
1000
-
0.01
-
Table 3: Proportions in formulation and PNEC for components
Max %w/w
Active
SoC1
8
9
Aquatic
PNEC mg/L
0.0005
0.0005
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CRF
16000
18000
Acceptable
risk ?
Yes
No
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SoC2
15
0.01
1500
Yes
Therefore because SoC1 has a higher CRF than for the Active Substance an
acceptable risk has not been demonstrated and the risk assessment should proceed on
to Tier 3. However for SoC2, because the CRF is lower than that of the active
substance, and because an acceptable risk has been demonstrated for that active
substance without the consideration of degradation, an acceptable risk can also be
concluded for SoC2.
Tier 3: Example calculations for scaled PEC of a SoC based on active substance
PEC
In the formulation described in Tier 2 above, SoC1 was not demonstrated to show an
acceptable risk at Tier 2 and further assessment was required. The product is used as a
PT8 wood preservative, and an acceptable risk to surface water has been
demonstrated for UC3 uses for the active substance following the calculation of PECs
in accordance with the PT8 ESD and considering the proposed formulation retention
rate and the leaching rate of the active substance of 10 % for Time 1 assessments and
100 % for Time 2 assessments. An active substance PEC of 0.04 μg/ L at Time 1 and
0.00016 μg/ L at Time 2 were calculated for the active substance. Because leaching
data are not available for SoC1, 100 % leaching must be assumed.
Table 4: Calculated PECs and risk assessment for an active substance and
comparative risk assessment for a SoC.
Leaching rate
Mm
PEC (μg/ L)
PEC/ PNEC
Max
Time 1 Time formulation
Time 1 Time 2 Time Time 2
concentrati
2
1
on (%w/w)
Active 10 % 100 %
8
720
0.04
0.00016 0.08 0.00032
SoC1
100 % 100 %
9
546
0.34
0.00014 0.68 0.00028
Therefore because the scaled PEC for surface for both Time 1 and Time 2
demonstrate an acceptable risk to surface (by virtue of the PEC/PNEC being < 1 for
both Time 1 and Time 2) an acceptable risk to surface water has been demonstrated
for SoC1.
It should be noted that the above example only considers surface water, but that an
acceptable risk is required to be demonstrated for all environmental compartments,
and therefore all environmental compartments should be considered. The principles of
the above calculation can also be applied to PEC calculations for other environmental
compartments and uses if the risk from an SoC cannot be demonstrated at lower tiers.
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Appendix 2 – Extract from the TNsG on Data Requirements
4.2 WHAT ARE SUBSTANCES OF CONCERN?
The Biocidal Products Directive (98/8/EC) has the following definition for a substance of
concern in Article 2(1)(e):
Substance of concern: Any substance, other than the active substance, which
has an inherent capacity to cause an adverse effect on humans, animals or the
environment and is present or is produced in a biocidal product in sufficient
concentration to create such an effect.
Such a substance, unless there are other grounds for concern, would be normally
a substance classified as dangerous according to Council Directive 67/548/EEC
of 27 June 1967 on the approximation of laws, regulations and administrative
provisions relating to classification, packaging and labelling of dangerous
substances, and present in the biocidal product at a concentration leading the
product to be regarded as dangerous within the meaning of Article 3 of Council
Directive 88/379/EEC of 7 June 1988 on the approximation of the laws,
regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous substances preparations.
(Amended by Directive 99/45/EC)
The substance is regarded as a substance of concern if:
1. the substance is included in Annex I of Council Directive 67/548/EEC, i.e. it is
classified as dangerous and its concentration in the product exceeds the
classification limit set in Council Directive 88/379/EEC, as amended by
Directive 1999/45/EC, for a particular dangerous property or the other
classification limit indicated for the substance in a preparation in Annex I of
Council Directive 67/548/EEC or causes that the overall sum of the
concentrations of dangerous substances in the product exceeds the limit for
classification of the preparation set in Council Directive 88/379/EEC, as
amended by Directive 1999/45/EC, for a particular dangerous property.
Concentration limits set for preparations concerning classification as
dangerous to the environment are given Directive 88/379/EEC as amended
by Directive 1999/45/EC;
2. the substance is not (yet) included in Annex I of Council Directive
67/548/EEC (or it is included in Annex I of Council Directive 67/548/EEC
but not evaluated for this particular dangerous property, e.g. dangerous to the
environment) and it is assessed to fulfil the criteria for a dangerous substance
specified in Council Directive 67/548/EEC and its concentration in the
product exceeds the classification limit set in Council Directive 88/379/EEC,
as amended by Directive 1999/45/EC, for a particular dangerous property or
causes that the overall sum of the concentrations of dangerous substances in
the product exceeds the limit for classification of the preparation set in
Council Directive 88/379/EEC, as amended by Directive 1999/45/EC, for a
particular dangerous property. Concentration limits set for preparations
concerning classification as dangerous are given in Directive 88/379/EEC
and by Directive 1999/45/EC;
3. there are other grounds for concern, for example:
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- serious doubts on dangerous properties not covered by the classification
criteria (e.g. toxicity to terrestrial organisms or endocrine effects);
- a substance in a biocidal product is present below the concentration limit
for classification set in Council Directive 88/379/EEC (as amended
by Directive 99/45/EC) but the substance is classified in Annex I of
Council Directive 67/548/EEC or otherwise known to have nonacceptable characteristics (carcinogenicity, mutagenicity, toxicity for
reproduction or sensitising properties) or the route of exposure is
especially relevant for biocides or the route of exposure can increase
the concentration of Council the substance following application;
- serious doubts on other unacceptable effects specified in the Directive,
Article 5(1) (e.g. unacceptable effects on indoor or workplace air
quality or by worker dermal exposure, resistance, unnecessary pain
for vertebrates);
- information on dangerous properties of structural relatives of the
substance; or
- information on the ability of the substance to form dangerous substances
e.g. in reaction with substances present in the environment.
It is always primarily the applicant who must identify all possible substances of concern in the
product and submit the basic data for risk characterisation (Art 8(6) in Directive). The
competent authority shall ask for more information or further testing if the data submitted is
not satisfactory or if additional information or testing is necessary to evaluate the risks of the
biocidal product.
4.3 DATA REQUIREMENTS FOR SUBSTANCES OF CONCERN
A basic data set is required for the preliminary risk characterisation of the identified
substances of concern. It should be noted that study reports need not be submitted, but all
information submitted must include a detailed description of the references and of the actual
source of data. Relevant sources include e.g.: databases, scientific publications, handbooks
and summaries collected and edited by scientific organisations or authorities. Also data
included in the Safety Data Sheet of the substance can be used, however, the original
reference should be given as well. The general rules on data protection laid down in the
Biocidal Products Directive have to be respected; i.e. a letter of access may in some cases be
required.
In some cases there may be only a limited amount of data available. The applicant, however,
is responsible to search for data from all sources which he or she may reasonably be expected
to have access to. Data and information additional to that indicated below may be required if a
preliminary risk characterisation indicates a need for such. No new tests on substances of
concern have to be made, unless so required by the competent authority due to a specific
concern.
Where appropriate, the corresponding guidance given in Chapters 2 and 3 on the information
to be provided on the active substance or the biocidal product applies here also. The number
given in parenthesis refers to the detailed data requirements in Chapter 2 or 3. For polymers,
the corresponding data which is relevant according to the Commission Directive 93/105/EC,
laying down Annex VII D containing information required for the technical dossier referred
to in Article 12 of the seventh amendment of Council Directive 67/548/EEC, should be
submitted. The general guidance given in Chapter 1 on, for example, acceptable grounds for
not submitting data is also applicable to substances of concern. If a preliminary quantitative or
qualitative risk assessment compiled in accordance with Chapter 2, paragraph B10 (data set
for the biocidal product) on the basis of the available test results and other data, shows the
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indication of any risk related to a substance of concern, there may be a need for further testing
in accordance with guidance of this Chapter and that applicable from Chapters 2 and 3. In
particular, it should be considered if it would be more appropriate to do a test with the
biocidal product, instead of a substance of concern, in accordance with the guidance in
Chapters 2 and 3, Part B, data set for the biocidal product, especially if there are two or more
substances of concern in the product.
All available data on the identified substances of concern must be submitted; if the applicant
believes that there is reasons for concern for a certain end-point, at least the Annex VII A data
(of directive 92/32/EEC) for that end-point is needed.
1 IDENTITY OF THE SUBSTANCE OF CONCERN
- as required in Chapter 2, Part B 2.2 (e.g. chemical name, CAS and EC
numbers)
- molecular mass
2 DATA ON PHYSICAL AND CHEMICAL PROPERTIES
- Melting and/or boiling points (Chapter 2, Part A 3.1)
- Volatility (Chapter 2, Part A 3.2)
• Vapour pressure
• Henry’s law constant
- Solubility in water (Chapter 2, Part A 3.5)
- Partition coefficient n-octanol/water, including if available effect of pH (5 to 9)
and temperature (Chapter 2, Part A 3.9)
- Thermal stability and if possible, identity of the thermal breakdown compounds
(Chapter 2, Part A 3.10)
- Other relevant data on physical and chemical properties (a full description on
physical and chemical properties in tabular form, e.g. reactive, flammable,
explosive and oxidising hazard.)
3 TOXICOLOGICAL AND METABOLIC DATA
A short summary evaluation of the basic toxicological properties of the substance of concern
(in accordance with the guidance given in Chapter 2, Part B 6.5):
- Information on acute toxicity
• Information on acute toxicity in oral route should always be given. If
exposure in dermal and/or inhalation route is expected, data on acute
toxicity in those routes should be given. (See the criteria in the Chapter 2
for testing of inhalation and dermal toxicity).
- Information on skin sensitisation in animal and/or human skin
- Information on dermal absorption should be submitted in cases where the
dermal exposure to the product is relevant.
- Information on mutagenicity
- Information on short term repeated dose toxicity,
- Information on long term repeated dose toxicity including carcinogenicity, if
available
- Information on reproduction toxicity, if available
- Human medical data and epidemiological data should be included, if available
(e.g. information on signs on acute poisonings, antidotes.)
- Other relevant toxicity data (e.g. toxicokinetics, neurotoxicity), if available
4 ECOTOXICOLOGICAL DATA
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It has been proposed that the acceptability of providing (Q) SAR estimates for some data gaps
instead of test results should be discussed. E.g. for substances for which no data are available
at all the aquatic effects should be estimated with the help of (Q) SAR. See Chapter 1 for
further information.
- Foreseeable routes of entry into the environment on the basis of the use
envisaged (in accordance with the guidance given in Chapter 2, Part B 7.1)
• Information on how the substance of concern can be released into the
environment due to handling it or from a waste water treatment plant, etc.,
to which compartment of the environment (soil, sediment, water, air), and
an estimation on how large the amounts released are.
• A description of sources of environmental exposure: for example
production, distribution, storage, mixing and loading, uses and disposal or
recovery. An indication of the measured or estimated extent of release:
frequency and intensity (e.g. dose and duration).
• A definition of aquatic recipients in detail: for instance surface water,
ground water, estuaries or a marine environment. An assessment of
possible ways of transformation and distribution.
• Possible information on representative measured concentrations or
monitoring data, for example, in waste water or in the environment or on
concentrations based on model calculations, using e.g. the EUSES model
(see Chapters 2 and 3).
- Available ecotoxicological information such as information from safety data
sheets (in accordance with the guidance given in Chapter 3, Part B 7.3) on
the following:
- Abiotic degradation (see Chapter 2, Part A 7.1.1.1)
- Hydrolysis as a function of pH
- Phototransformation in water
- Biotic degradation (see Chapter 2, Part A 7.1.1.2)
- Ready biodegradability
- Adsorption/desorption (see Chapter 2, Part A 7.1.3)
- Aquatic toxicity, basic information (see Chapter 2, Part A 7.4.1)
- Acute toxicity to fish
- Acute toxicity to Daphnia magna
- Growth inhibition test on algae
- Inhibition of microbiological activity
- Terrestrial toxicity, basic information
- Inhibition of microbiological activity (see Chapter 2, Part A 7.5.1)
- Bioconcentration (see Chapter 2, Part A 7.5.2).
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