Analysis of Alternatives for Biocidal Active Substances
Analysis of Alternatives for Biocidal Active Substances
Identifying an alternative to a biocidal active substance is not simply a question of finding another chemical with a similar purpose. A potential alternative needs to be considered in relation to the function it performs, the uses it supports, its effectiveness, risks, technical feasibility, availability and the practical and economic consequences of substitution.
These questions can become particularly important where an active substance meets the exclusion criteria under the Biocidal Products Regulation (BPR), is identified as a candidate for substitution, or where the availability of alternatives is relevant to an approval or renewal decision.
An analysis of alternatives (AoA) provides a structured way of identifying potential alternatives and assessing whether they could realistically replace the active substance for the uses concerned.
What is an analysis of alternatives for biocides?
An analysis of alternatives examines possible alternative substances, products, technologies or non-chemical approaches and assesses their suitability for the uses currently performed by a biocidal active substance.
The purpose is not simply to compile a list of possible substitutes. The assessment needs to establish what function must be replaced and examine whether potential alternatives can deliver that function in practice.
Depending on the regulatory context, this can require consideration of:
- the function performed by the active substance;
- the uses and sectors that depend on it;
- potential chemical and non-chemical alternatives;
- efficacy and technical performance;
- human health and environmental considerations;
- technical feasibility;
- availability and implementation;
- economic feasibility and practical implications; and
- uncertainties and evidence gaps.
ECHA has published a specific framework to support this process:
The guidance provides a common framework for applicants and authorities considering alternatives to biocidal active substances.
When can analysis of alternatives be relevant?
The relevance of an AoA depends on the regulatory circumstances surrounding the active substance.
Under the EU BPR, active substances with particular hazardous properties may meet the exclusion criteria in Article 5. Such substances should in principle not be approved unless one of the conditions allowing a derogation is met.
One of the issues that can be relevant to this assessment is whether suitable alternatives are available.
The BPR also establishes criteria under Article 10 for identifying active substances as candidates for substitution.
When an evaluating competent authority identifies an active substance as a potential candidate for substitution, ECHA normally launches a public consultation before the opinion on approval or renewal is submitted to the European Commission. The consultation seeks information, including information on available substitutes or alternatives.
ECHA provides current information on these consultations here:
ECHA – Consultations on potential candidates for substitution and derogation conditions
An AoA can therefore help applicants and other affected organisations provide structured evidence on whether alternatives exist and, importantly, whether they are genuinely capable of replacing the substance for the relevant uses.
Start with the function and uses
A useful analysis begins by establishing what the active substance actually does and the conditions under which that function is required.
The same active substance may support different product types, applications, sectors and operating conditions. An alternative that is suitable for one use may therefore be unsuitable for another.
The assessment may need to distinguish between factors such as:
- target organisms;
- required level and duration of efficacy;
- application method;
- conditions of use;
- materials or processes being protected;
- technical or performance standards;
- user requirements; and
- sector-specific constraints.
Defining these requirements provides the basis against which potential alternatives can be identified and assessed.
Without an appropriate understanding of function and use, there is a risk of identifying theoretical alternatives that cannot provide an equivalent or acceptable outcome in practice.
Identifying potential alternatives
Potential alternatives are not necessarily limited to other biocidal active substances.
Depending on the use, they may include:
- alternative active substances;
- different biocidal products or formulations;
- alternative treatment technologies;
- changes to processes or operating practices;
- physical or mechanical controls;
- prevention measures; or
- combinations of chemical and non-chemical approaches.
The search should be sufficiently broad to identify credible possibilities while remaining relevant to the functions and uses being assessed.
Information may come from regulatory databases, scientific literature, market information, manufacturers, downstream users, technology providers and other stakeholders with knowledge of the relevant applications.
The existence of an alternative somewhere in the market does not by itself demonstrate that it is a suitable replacement for every use.
Technical feasibility and efficacy
A potential alternative needs to be capable of delivering the required function under the relevant conditions.
This may involve consideration of efficacy against the target organism as well as factors such as treatment conditions, compatibility with existing processes or materials, durability, operating requirements and the consequences of adopting a different control method.
Evidence requirements will depend on the particular use and alternative being assessed.
Where an alternative cannot achieve the necessary performance, the basis for that conclusion should be clearly documented. Similarly, where further testing or development could potentially overcome existing limitations, this should be distinguished from an alternative that is fundamentally unsuitable.
Human health and environmental considerations
Substitution should not result in the replacement of one regulatory concern with another.
Potential alternatives therefore need to be considered in terms of their human health and environmental properties and the exposure associated with their intended use.
This can include consideration of:
- hazard classifications and intrinsic properties;
- human and environmental exposure;
- risk management requirements;
- regulatory status; and
- potential emerging regulatory concerns.
The appropriate comparison will depend on the information available and the nature of the alternatives.
A lower hazard in one respect does not necessarily mean that an alternative provides a lower overall risk. The assessment should consider the characteristics that are material to the particular use and substitution decision.
Availability and implementation
An alternative may appear technically suitable but still not be available at the scale, quality or timeframe required for substitution.
The assessment may therefore need to consider:
- whether the alternative is commercially available;
- available production capacity;
- access to technology or equipment;
- qualification or certification requirements;
- supply-chain constraints;
- investment requirements;
- reformulation or process changes;
- customer acceptance; and
- the time needed for implementation.
Where an alternative is under development, it can also be useful to distinguish between its present status and its potential future feasibility.
Research and development activity, testing programmes and realistic implementation timescales can therefore form an important part of the evidence.
Economic and practical implications
Economic assessment should go beyond comparing the unit price of the existing substance and an alternative.
Substitution can affect production processes, equipment, treatment frequency, labour, energy and resource requirements, product performance, waste, supply chains and other operating costs.
Relevant questions can include:
- what changes would be required to adopt the alternative;
- what investment would be needed;
- whether operating costs would change;
- whether additional quantities or more frequent treatment would be required;
- whether production capacity or output could be affected;
- whether there are implications for product quality or longevity; and
- who would ultimately bear the additional costs.
The significance of these effects depends on the regulatory question. In some cases, a more detailed socio-economic analysis may be needed to assess the consequences of substitution or of losing particular uses.
Related RPA page: Socio-economic Analysis for Biocides
Evidence from users and supply chains
For specialised or technically demanding uses, information held by manufacturers alone may not be sufficient to understand whether an alternative is workable.
Downstream users and other organisations within the supply chain can provide evidence on practical requirements, performance constraints, current alternatives, implementation barriers and the consequences of substitution.
Structured evidence gathering can therefore be an important component of an AoA, particularly where an active substance supports multiple uses or sectors.
This evidence needs to be assessed critically. Statements that an alternative is unavailable or unsuitable are more useful where the underlying technical, economic or practical reasons are clearly demonstrated.
Analysis of alternatives and socio-economic analysis
AoA and socio-economic analysis can address different but closely connected questions.
An AoA considers whether suitable alternatives exist and what would be required to substitute the active substance.
SEA can examine the wider consequences associated with different regulatory outcomes, including the costs and benefits affecting manufacturers, downstream users, consumers and wider society.
Information generated through the AoA can therefore provide important inputs to socio-economic analysis. For example, the costs, implementation timescales and performance implications of alternatives can influence the consequences associated with substitution.
The scope of each assessment should nevertheless be determined by the regulatory decision and evidence requirements concerned.
Analysis of alternatives and comparative assessment are not the same process
Analysis of alternatives for an active substance should be distinguished from the comparative assessment of biocidal products required under Article 23 of the EU BPR.
Where a biocidal product contains an active substance identified as a candidate for substitution, the competent authority carries out a comparative assessment as part of the evaluation of an application for product authorisation or renewal.
The regulatory test considers whether another authorised biocidal product or a non-chemical control or prevention method presents a significantly lower overall risk, is sufficiently effective and presents no other significant economic or practical disadvantages, while also taking account of chemical diversity needed to minimise the occurrence of resistance.
An AoA concerning an active substance can provide evidence relevant to questions about substitution, but it should not be treated as interchangeable with the product-level comparative assessment.
Related RPA pages: Analysis of Alternatives for Biocidal Active Substances and Candidates for Substitution and Comparative Assessment
Developing a robust analysis of alternatives
The depth of an AoA should reflect the substance, uses, regulatory context and significance of the decision being considered.
A robust assessment will normally require:
- a clear definition of the functions and uses that need to be replaced;
- a systematic search for potential alternatives;
- transparent criteria for screening those alternatives;
- assessment of technical feasibility and efficacy;
- consideration of human health and environmental implications;
- assessment of availability and implementation requirements;
- consideration of economic and practical consequences;
- clear documentation of the evidence used;
- identification of uncertainty and evidence gaps; and
- conclusions that follow from the evidence rather than from assumptions about the availability or suitability of alternatives.
The assessment may need to be iterative. New technical, regulatory or market information can change the understanding of what alternatives are feasible and what would be required to implement them.
How RPA contributes to analysis of alternatives
Analysis of alternatives often requires evidence from several disciplines to be brought together into a coherent assessment.
RPA can contribute through:
- defining the scope and regulatory context of the assessment;
- identifying and screening potential alternatives;
- scientific and regulatory evidence review;
- assessment of technical and practical feasibility;
- economic analysis of alternative options;
- stakeholder and supply-chain evidence gathering;
- assessment of implementation barriers and timescales;
- integration of AoA evidence with socio-economic analysis; and
- development of transparent evidence and conclusions for regulatory decision-making.
The emphasis is on establishing what the available evidence demonstrates for the particular functions and uses being assessed, including where uncertainty remains or additional evidence may be required.
Official guidance and legislation
ECHA – Consultations on potential candidates for substitution and derogation conditions