Substances of Concern
Substances of Concern (SoC) are co-formulants in biocidal products, in addition to the active substance, which can pose a potential risk for humans and the environment. The Biocidal Products Directive and Biocidal Products Regulation both state explicitly that SoCs must be included in the risk assessment.
Assessment of Substances of Concern
For the the assessment of a SoC applicants are responsable to submit data on the aspect human toxicology. For environmental aspects, the situation will remain as published in the Government Gazette (Staatscourant),December 23, 2013; data filing requirements regarding SoCs for these aspects will not yet be assigned to applicants. However, applicants retain the right to voluntarily submit an environmental data dossier for SoCs.
Humane toxicology guidance
The SoC guidance does not have any specific dossier requirements for SoCs. This is because the human toxicology guidance uses existing limit values for SoCs, including established Dutch or EU limit values, AELs (Assigned Exposure Limits) if a final draft CAR is available, or DNELs (Derived No Effect Levels)/DMELs (Derived Minimal Effect Levels) established under REACH. Some limit values are based on publicly accessible data, such as the limit values in the Health and Safety Act, but some limit values have been derived from proprietary data that is protected. Applicants must therefore determine whether limit values are based on protected data; if necessary, they must gain access to the data by means of a letter of access. Applicants may also submit their own data files for the assessment of SoCs.
Summary of methodology
Co-formulants that are considered to be potential SoCs are the following:
- substances with established limit values based on public data (EU or Dutch; the latter obviously applies only to the Netherlands; other Member States have their own limits values with which they comply)
- active substances for which a draft final CAR (Competent Authority Report) is available (and therefore a standard which can be used to determine whether they are SOCs)
- all substances that contribute to the classification and labelling of the formulation.
- substances that are included on the “candidate list” for substitution under REACH (in practice, these are the Category 1 CMR substances and endocrine disruptors).
For substances that comply with criteria 1, 2 and 5, a quantitative assessment is mandatory. Some additional explanation is required for substances that contribute to the classification and labelling of the formulation and synergists (criteria 3 and 4).
Substances that comply with criterion 3 are classified into 4 “bands” (A through D). If the substance has been classified in one of the first two bands (the substance contributes only to short-term effects with various degrees of severity, e.g. skin irritation or skin damage, eye irritation or eye damage, acute toxicity in various categories), no quantitative assessment will be performed and it will be concluded that the effects are covered by the classification and labelling of the formulation. If the substance has been classified for long-term effects (bands C and D, such as repeated dose toxicity, carcinogenicity, reprotoxicity, and mutagenicity), a quantitative assessment will be conducted. Using substances from band D as co-formulants is strongly discouraged in principle (Category 1 CMR substances) and can also have consequences for the authorisation. Criterion 4 is rarely applied in practice because in most cases no information is available about the synergistic effects of substances.