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Major changes on request

Authorisation holders can at any time apply for a major change: an amendment of an existing authorisation which is neither an administrative change nor a minor change.

Characteristics

Major changes: when a need for reassessment of the risk and the efficacy can be expected to fulfil the conditions for authorisation. Major changes are described in detail in the Annex to Commission Implementing Regulation (EU) No 354/2013. More details are given in ECHA’s Practical guide on BPR – Changes of biocidal products.

Legal basis

Applications for changes of authorisations find their legal basis in Chapter IX of the BPR and in  Commission Implementing Regulation (EU) No 354/2013.

Application type criteria

  • Changes can be made to both single products and to biocidal product families, and to national authorisations as well as Union authorisations.
  • Independent of how the authorisation of a product was originally granted (national application, mutual recognition, same biocidal product or Union authorisation), it can be changed.
  • Changes of national authorisations can be applied for in single countries, or in various countries in parallel. Applications for administrative changes are handled by the MS independently. Minor and major changes can be applied for in parallel.
  • Changes of Union authorisations must be submitted to the European Chemicals Agency (ECHA)

Details can also be found in ECHA’s Practical guide on BPR - Changes of biocidal Products.

Information requirements

Article 5 of Commission Implementing Regulation (EU) No 354/2013 lists the requirements for an application for a change of the authorisation of a biocidal product. With regard to practical information for this type of application on characteristics, BPR requirements and best practices to fulfil them, check ECHA’s Practical Guide on BPR - Changes of biocidal Products.

Registration process

Your application must be submitted through ECHA’s information system R4BP and, if applicable, refer to a product dossier in IUCLID. The validation/evaluation procedures differ for the different types of changes, and are reflected under Timeline.

Major changes: Timeline

Timelines for of applications for major amendments are described in Chapters II and III of Commission Implementing Regulation (EU) No 354/2013.

  • Application holders submits application (to all MS concerned). Fee must be paid within 30 days.
  • Validation by reference MS within 30 days (if necessary 90 days-stop-the clock to provide additional information).
  • Evaluation by refMS within 180 days and sends assessment report (and SPC) to other MS and applicant (if necessary 90 days-stop-the clock to provide additional information, followed by another 30 days for validation by refMS).
  • 90 days to reach agreement among MS.
  • Within 30 days after agreement: refMS informs applicants and all MS amend authorisation.
    Change already agreed by another member state:
    • major change; within 90 days MS must disagree or agree and amend authorisation

NB The above schemes are for national authorisations. In case of the change of a Union authorisation, the notification or application must be sumitted to ECHA.

The procedure and timelines are identical for minor changes, with the following differences:

  • ECHA prepares an opinion (instead of an assessment report) which is not reviewed by MS
  • Where relevant, within 30 days after submission of the opinion ECHA transmits to the Commission the revised SPC in all official languages of the Union

Major change of Union authorisation:

As for major change of national authorisation, except:

  • eCA validates within 30 days after the Agency accepted the authorisation
  • eCA evaluates the change and sends assessment report (and SPC) to ECHA (within 180 days)
    prior to submission to ECHA< applicant has 30 days to comment
  • within 90 days after receipt of eCA’s conclusions, ECHA submits an opinion to the commission
  • Where relevant, within 30 days after submission of the opinion ECHA transmits to the Commission the revised SPC in all official languages of the Union.

Instructions for submission

Submission must be done via R4BP. Instructions are given in ECHA’s Biocides Submission Manual on using R4BP.

For major changes the application must refer to the product dossier in IUCLID and must include the relevant sections of a draft Product Assessment Report (PAR) in Word format. If relevant, a Summary of Product Characteristics (SPC) in xml format must be provided (preparation in SPC Editor).

Instructions can be found on the ECHA website (national applications)  and in ECHA’s Biocides Submission Manual: National authorisations.