The EU Biocidal Products Regulation (Regulation (EU) 528/2012), abbreviated EU BPR, has applied since 1 September 2013. It requires all biocidal products to be authorised before being placed on the market, and the active substances in them must already have been approved by the European Commission.
Download Regulation (EU) 528/2012 at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0528
1. Basic concepts of the EU BPR, in one chart:
2. BPR biocidal product authorisation (BPA) process, in one chart:
3. BPR treated article registration (BTPR): the main types of technical documents usually required for registration, in one chart:
“Under the EU BPR framework, biocidal product authorisation and treated article registration differ significantly in regulatory logic, technical documentation requirements and compliance route”
4. Differences in core definitions and regulated subjects
5. Differences in process steps
6. Differences in technical documentation
7. Differences in risk assessment focus
8. Differences in labelling requirements
9. Compliance challenges and recommendations
(1) Biocidal product authorisation
Challenge: active substance evaluation takes a long time and data costs are very high.
Recommendation: prefer already-approved active substances, or purchase letters of access to data through data-sharing arrangements.
(2) Treated article registration
Challenge: the treatment process must meet GLP (Good Laboratory Practice) standards, and the continued effectiveness of the biocidal function of the treated article must be demonstrated.
Recommendation: work with specialist laboratories and plan treatment process validation and migration testing in advance.
10. Q&A
Q: Do MDR medical device products such as alkaline multi-enzyme cleaners, neutral multi-enzyme cleaners, all-purpose multi-enzyme cleaners and citric acid disinfectant need to comply with Regulation (EU) No 528/2012 and REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)?
A: REACH requires chemicals imported into or manufactured in Europe to go through registration, evaluation, authorisation and restriction procedures. If substances in these cleaners and disinfectants are intended to be released under normal and reasonably foreseeable conditions of use, and an individual manufacturer or importer produces or imports more than 1 tonne per year, they must be registered in accordance with the relevant provisions.
At the same time, the MDR also sets requirements for chemical substances in medical devices: devices and their parts and materials must be checked to avoid substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A or 1B, among others. If the testing and assessment requirements of REACH and other directives have already been met, the chemical substance testing required by the MDR need not be repeated.
Q: Under Regulation (EU) 528/2012, is biocidal product authorisation or treated article registration required?
A: (1) Citric acid disinfectant: biocidal product authorisation (BPA) is required. Under the BPR, disinfectants are typical biocidal products and can only be placed on the market after approval of the active substance and authorisation of the product. Regarding cross-compliance with the MDR, a citric acid disinfectant must meet both the MDR’s biocompatibility requirements (ISO 10993-5) and the BPR’s verification of disinfection efficacy. For example, if it is used to disinfect haemodialysis machines, it must pass compatibility testing under the Standard Operating Procedures for Blood Purification
(2) Multi-enzyme cleaners are medical device cleaning agents. Under the BPR, if they contain no antimicrobial ingredients and no disinfecting function is claimed, they are not biocidal products and require neither BPA nor BTPR (treated article registration). Multi-enzyme cleaners must meet the MDR’s chemical safety requirements, and if they contain enzymes they must pass biocompatibility testing (ISO 10993-5).
(3) If a multi-enzyme cleaner contains antimicrobial ingredients, even without claiming a disinfecting function, it is a biocidal product and requires BPA.
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