Biocidal Product Authorisation and Market Access
Biocidal Product Authorisation and Market Access
Approval of a biocidal active substance does not automatically allow every product containing it to be placed on the market.
Biocidal products generally require authorisation for the market in which they will be supplied. The appropriate authorisation route depends on factors including the active substances in the product, the product type, intended uses, composition and geographic markets concerned.
For companies managing products across the EU, Great Britain and Northern Ireland, market access therefore requires consideration of both active substance status and product authorisation.
When does a biocidal product require authorisation?
Under the EU Biocidal Products Regulation (EU BPR), a biocidal product must not normally be made available on the market or used unless it has been authorised in accordance with the Regulation.
Before an authorisation can normally be granted, the active substances contained in the product must be approved for the relevant product type and the applicable conditions of those approvals must be met.
The product itself must also satisfy the conditions for authorisation. These include demonstrating that it is sufficiently effective and that, when used as authorised, it does not have unacceptable effects on human or animal health, the environment or target organisms.
Authorisation therefore involves assessment of the finished biocidal product and its intended uses, rather than relying only on the assessment already undertaken for the active substance.
The legal requirements are set out in:
Active substance status and product market access
The first step in determining the regulatory route for a biocidal product is establishing the status of each active substance for the relevant product type.
An active substance may be:
- approved;
- under review or assessment;
- subject to a non-approval decision; or
- eligible for particular regulatory arrangements.
The regulatory position can affect whether the product requires authorisation immediately, remains within transitional arrangements or can continue to be supplied only for a limited period.
Changes to active substance approval can also affect existing product authorisations. For example, changes to approval conditions or a decision not to renew an active substance may require associated product authorisations to be reviewed, amended or cancelled.
Product-level regulatory strategy therefore needs to take account of developments affecting the underlying active substances.
Related RPA page: Active Substance Approval and Renewal
EU national authorisation
A company intending to place a biocidal product on the market in a particular EU Member State can apply for national authorisation in that country.
The relevant Member State competent authority evaluates whether the product meets the conditions for authorisation under the BPR.
The application normally includes information addressing the identity and properties of the product, efficacy, intended uses, human health and environmental risks and the active substances it contains.
The resulting authorisation specifies the conditions under which the product may be made available and used.
Further information is available from:
ECHA – National authorisation and mutual recognition
Mutual recognition
Where a business intends to supply a product in several EU Member States, mutual recognition can provide a route for extending a national authorisation to additional countries.
Under mutual recognition in sequence, a product is first authorised in one Member State and the authorisation holder subsequently asks other Member States to recognise that authorisation.
Under mutual recognition in parallel, the application for national authorisation in a reference Member State and the applications for recognition in other Member States are progressed together.
Mutual recognition does not mean that every issue will automatically be resolved identically in every Member State. Where authorities disagree on whether the conditions for authorisation have been satisfied, the BPR contains procedures for resolving those disagreements.
The choice of reference Member State, intended markets and regulatory strategy can therefore be important when planning an application covering several countries.
ECHA – National authorisation and mutual recognition
Union authorisation
For eligible products, Union authorisation provides an alternative to obtaining separate national authorisations and mutual recognitions across multiple EU markets.
An application for Union authorisation is evaluated by a competent authority, followed by consideration through ECHA’s Biocidal Products Committee. The European Commission takes the authorisation decision.
Where granted, a Union authorisation allows the product to be made available across the territories covered by the authorisation without obtaining separate national authorisations.
Whether this is an appropriate route depends on the product type, intended uses and markets concerned.
Further information is available from:
Simplified authorisation
The EU BPR also provides a simplified authorisation procedure for certain products meeting specified conditions.
To qualify, the product must meet all of the applicable requirements under Article 25. These include requirements relating to the active substances contained in the product, substances of concern, nanomaterials, efficacy and whether personal protective equipment is required for handling and intended use.
The procedure is intended for products with a more favourable human health, animal health and environmental profile.
A product granted simplified authorisation can generally be made available in other EU Member States following the required notification rather than undergoing mutual recognition.
ECHA – Simplified authorisation
Product authorisation in Great Britain
Biocidal products supplied in England, Scotland and Wales are regulated under the GB Biocidal Products Regulation (GB BPR).
Where product authorisation is required, HSE can grant a national authorisation for a biocidal product or biocidal product family in Great Britain.
The active substances must first meet the applicable GB requirements for the relevant product type.
The prospective authorisation holder must also be established in the UK. Once authorised, the product may be supplied on the GB market subject to the terms and conditions of the authorisation.
HSE provides a number of product-level regulatory routes, including:
- national authorisation;
- same biocidal product authorisation;
- simplified authorisation;
- renewal and changes to existing authorisations; and
- specific authorisations or permits where the relevant statutory conditions are met.
Further information is available from:
Northern Ireland
The EU BPR applies to biocidal products made available on the Northern Ireland market.
The applicable application route depends on the type of authorisation concerned. HSE remains involved in several Northern Ireland national authorisation processes, while applications such as Union authorisation are handled through the EU system.
An authorisation holder for an EU BPR product authorisation in Northern Ireland must be established in the EU, including Northern Ireland.
Businesses supplying products across Great Britain and Northern Ireland therefore need to consider the regulatory requirements for each market separately.
An authorisation or regulatory status applying in one market should not be assumed automatically to provide access to the other.
Further information is available from:
HSE – Biocides regulation in Northern Ireland
Article 95 and the active substance supply chain
Product authorisation is not the only consideration affecting market access.
The BPR also includes requirements relating to approved active substance suppliers and product suppliers under Article 95.
Businesses placing biocidal products on the market need to establish whether the relevant active substance/product type combination is supported by a supplier included on the applicable Article 95 list.
For UK markets, the relevant requirements differ between Great Britain and Northern Ireland, reflecting the operation of GB BPR and EU BPR respectively.
HSE summarises the steps organisations should consider when bringing a biocidal product to the UK market:
HSE – How to get a biocidal product on the UK market
Product families and related products
Not every product necessarily needs to be approached as a completely independent authorisation.
The BPR provides mechanisms for biocidal product families, where products meeting the applicable criteria can be covered within a family authorisation.
There are also procedures for obtaining authorisation for a same biocidal product where the product is identical to a reference product or product family within the scope of the applicable rules.
These routes can be relevant where companies manage multiple formulations, trade names or related products.
The appropriate approach depends on the relationship between the products, the data available and the regulatory markets concerned.
ECHA – Same biocidal product authorisation
HSE – Same biocidal product authorisation
Candidates for substitution and comparative assessment
Additional considerations apply where a biocidal product contains an active substance that has been identified as a candidate for substitution.
Under Article 23 of the EU BPR, the competent authority must undertake a comparative assessment as part of an application for authorisation or renewal of a product containing a candidate for substitution.
The assessment considers whether another authorised biocidal product or a non-chemical control or prevention method:
- presents a significantly lower overall risk;
- is sufficiently effective;
- presents no other significant economic or practical disadvantages; and
- provides sufficient chemical diversity to minimise the development of resistance.
Where the statutory conditions are satisfied, the authorisation of the product containing the candidate for substitution may be restricted or prohibited.
Product authorisation strategy can therefore require consideration not only of the product’s own safety and efficacy, but also of the alternatives available for the uses concerned.
Related RPA page: Candidates for Substitution and Comparative Assessment
Maintaining an authorisation
Obtaining an authorisation is not necessarily the end of the regulatory process.
Authorisations are granted for a defined period and may need to be renewed. Changes to the product, its uses, composition or other conditions may also require regulatory action.
Organisations may therefore need to monitor:
- the expiry date of the product authorisation;
- active substance approval and renewal;
- changes to active substance approval conditions;
- changes in classification or regulatory requirements;
- proposed changes to the product or its uses;
- changes in suppliers or data access;
- Article 95 status; and
- regulatory developments affecting the relevant markets.
Where the underlying active substance approval is amended or cancelled, associated product authorisations may also need to be reconsidered.
Market access therefore depends on continuing regulatory management rather than simply obtaining an initial authorisation.
Developing a product authorisation and market-access strategy
The appropriate regulatory route will depend on the product and commercial objectives.
Questions to consider can include:
- In which markets will the product be supplied?
- What is the regulatory status of each active substance?
- Which product types and uses need to be covered?
- Is national, mutual recognition, Union or simplified authorisation potentially appropriate?
- Could a product family or same biocidal product route be relevant?
- What data are available and what additional evidence is required?
- Are there data-access or Article 95 considerations?
- Is any active substance a candidate for substitution?
- What implications could active substance renewal have for the product?
- What future markets or product variations need to be accommodated?
Considering these issues early can help align the authorisation strategy with the intended product portfolio and markets rather than addressing each application in isolation.
How RPA contributes to product authorisation and market access
RPA’s work can include:
- assessing the regulatory status of active substances and products;
- reviewing potential authorisation routes;
- developing regulatory and market-access strategy;
- assessing evidence and data requirements;
- scientific and regulatory evidence review;
- considering active substance dependencies and renewal implications;
- analysis of alternatives and comparative-assessment issues;
- assessing market and portfolio implications of regulatory decisions; and
- supporting evidence development for complex regulatory questions.
The appropriate support depends on the product, active substances, intended uses and markets involved. The focus is on understanding the regulatory requirements and their implications for the decisions the organisation needs to make.
Official guidance and legislation
ECHA – Authorisation of biocidal products
ECHA – National authorisation and mutual recognition
ECHA – Simplified authorisation
HSE – How to get a biocidal product on the UK market