- Taking stock: second peak conquered
- Smaller companies share their experiences on REACH registration
- Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product
- Are you importing or exporting hazardous chemicals?
- ENES5: Focus on mixtures
- How to find information about chemicals on ECHA's website
- First substance evaluation decisions to be finalised
- Lost in translation? Go to ECHA-term
- ECHA Science: Evaluation of grouping and read-across
- Wanted: practical examples from industry
- Member States agree on the practical actions of the SVHC Roadmap 2020
- Brazil interested in learning from ECHA's experiences
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Article related to: biocides
Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product
Does your biocidal product contain an active substance which comes from an alternative source that differs from the reference source of the approved active substance? An alternative source means that the manufacturing process, the manufacturing location or the manufacturer of the active substance is different.
If this is the case, you need to ask ECHA to assess whether your active substance is technically equivalent to the one already approved before you can submit an application for biocidal product authorisation.
- BPR dossier creation/IUCLID Quick Guide, available on the IUCLID website.
- Biocides Submission Manual 1: Using IUCLID for biocide applications, available on ECHA's website.
- Assessment of technical equivalence
- All guidance on biocides legislation
- All biocides submission manuals
- IUCLID 5 support documents
- ECHA's YouTube channel with video tutorials
- All supporting document templates for biocides
- BPR Fee Regulation
Did you know?
The obligation to assess the technical equivalence of your active substance before applying for a product authorisation is based on the Commission Delegated Regulation (EU) No 837/2013 that is amending Annex III of the Biocidal Products Regulation.
It states that the biocidal product may be authorised even if one or more of the active substances contained therein has been manufactured in a different location or according to a different process, including from different starting materials, as long as it can be ensured that those active substances do not have significantly more hazardous properties than the one that has been evaluated for the purpose of approval.
The technical equivalence assessment can only be made for already approved substances. If your alternative source for an active substance is still under review, you will soon have the possibility to apply for the new chemical similarity service, which ECHA plans to launch in early 2014.
Infograph: Steps that you need to take to get the technical equivalence of your active substance assessed.
Text by Päivi Jokiniemi
Top image: Fotolia
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)