Substances of Concern – Proposed Draft UK Position for Biocidal Products

February 2012

Comments_PA&MRFG-May12-Doc.6c

Substances of Concern – Proposed Draft UK Position for Biocidal Products

1. Introduction

This proposal for how to assess substances of concern (SoC) applies to biocidal products authorised under the Biocidal Products Directive (BPD) as well as the new Biocidal Products Regulation. The document therefore refers to both legal texts. Differences in the assessment approach owing to the two different legal texts are indicated in footnotes.

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 in the introduction to 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.

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).

The current TNsG on data requirements specify what the “other grounds for concern” mentioned in the definition are (s. Appendix 2). Another ground for concern is seen for substances, for which a threshold value (e.g. AEL, OEL, DNEL) is available, but which are not classified according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.

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).’

Data also has to be provided if other grounds of concern have been identified.

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?’ (s. Appendix 2) that:

‘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 (s. Appendix 2)::

‘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 PAMRFG-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

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. If an AEL or similar threshold value already exists for a SoC assigned to Band A or B, a quantitative assessment should be performed.

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, R66, R67 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 and additional measures, as appropriate, should be applied. Additional measures include additional phrases, modification of the formulation/package design/size to reduce exposure, mandatory addition of protective gloves to the package, etc. Such products can be used by professional and non-professional users (consumers). It should be noted that a full quantitative risk assessment is not usually performed for acute toxicity or irritant/sensitising effects leading to classification . If the relevant formulation studies 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, R48/23/24/25, R26, R27, R28, or R39, R42 or R64 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. Such products should be restricted to professional users. If significant exposure cannot be excluded, appropriate risk mitigation measures, in the form of the safety phrases triggered by the relevant R-phrases and additional measures, as appropriate, should be applied. Additional safety measures include additional phrases, modification of the formulation/package design/size to reduce exposure, etc.

BAND C - Products classified with Repr Cat 1, Cat 2 (R60, R61), Repr Cat 3 (R62, R63), Carc Cat 3 (R40), R48/23/24/25, , R48/20/21/22 or R42 under the DPD, requiring the assessment of relevant SoCs. Products not classified (on the basis of SoC) but containing substances for which other grounds of concern have been identified as well as

A Quantitative risk assessment for the substances of concern has to be performed. 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.