Biocidal Products – EU Procedures
The registration of biocidal products via European procedures follows the principles outlined in Regulation (EU) No 528/2012.
These procedures apply to biocidal products where all active substances are either:
- Approved for the relevant product-type (PT) under the review programme, or
- Listed in Annex I of Regulation (EU) No 528/2012 as low-risk substances for human health and the environment.
Depending on the status of the active substances, the following authorisation procedures are available:
- National authorisation – valid in the specific EU Member State.
- Mutual Recognition in Sequence (MRS) – applying for national authorisation in one Member State after it has been authorised in another.
- Mutual Recognition in Parallel (MRP) – simultaneous application for recognition in multiple Member States after initial authorisation.
- Parallel Trade Permit – allows market access in a Member State for a product authorised in another Member State, if considered identical.
- Union Authorisation – valid in all EU Member States.
For products containing only Annex I substances, a simplified procedure is available, allowing authorisation that can be valid across the EU after notification in that country.
National Authorisation and Mutual Recognition
National Authorisation: Companies must apply through the R4BP system in the target Member State. The competent authority evaluates the application within 365 days. Applications must contain detailed data on the product’s properties, efficacy, and safety. They must also include relevant studies conducted on the product and a risk analysis.
Mutual Recognition: If a company holds a national authorisation, it can request recognition in other Member States via sequential or parallel recognition.
- Sequential Mutual Recognition: First obtain authorisation in one Member State, then apply to others.
- Parallel Mutual Recognition: Apply in multiple Member States simultaneously, with one acting as the reference.
Applicants submit all mutual recognition applications through R4BP. The process typically takes around 5 months. If disagreements arise, authorities escalate them to the Coordination Group or the European Commission, which may involve ECHA for scientific advice.
Parallel Trade Permit
Under Article 53 of Regulation (EU) No 528/2012, a parallel trade permit can be granted if a product authorised in one Member State is considered identical to a reference product authorised in the target country.
Products are deemed identical if:
- Manufactured by the same or related company, using the same production process.
- Identical in specification, active substances, and formulation type.
- Identical in co-formulants (non-active substances).
- Same or equivalent packaging material and design, with no added risks.
The permit mirrors the conditions and validity of the reference authorisation. Applications are submitted via R4BP with supporting documentation and fee payment.
Union Authorisation
This procedure enables companies to market biocidal products across the entire EU with a single authorisation, avoiding individual national submissions.
Union Authorisation is applicable to products suitable for harmonised use across Member States, except those with exclusion-criteria substances and PTs 14, 15, 17, 20, and 21.
Availability based on active substance status:
- New substances: Eligible from 1 September 2013.
- Existing substances:
- PTs 1, 3, 4, 5, 18, 19 – from 1 September 2013
- PTs 2, 6, 13 – from 1 January 2017
- PTs 7, 8, 9, 10, 11, 12, 16, 22 – from 1 January 2020
ECHA lists authorised Union products on its website.
Simplified Authorisation Procedure
This aims to promote use of low-risk biocidal products. To qualify, a product must:
- Contain only Annex I active substances, without restrictions.
- Contain no potentially hazardous substances.
- Contain no nanomaterials.
- Be sufficiently effective.
- Not require personal protective equipment (PPE) during normal use.
Applicants submit via R4BP and designate the evaluating Member State. Once authorised, the product may be placed on other EU markets without mutual recognition, provided each Member State is notified at least 30 days prior to market entry via R4BP.