Odbor za biocidne proizvode
Odbor za biocidne proizvode
Odbor za biocidne proizvode (v nadaljnjem besedilu „BPC") pripravlja mnenja agencije ECHA v zvezi s številnimi postopki iz uredbe o biocidnih proizvodih (BPR). Končne odločitve sprejme Evropska komisija. Postopki so naslednji:
- vloge za odobritev ali podaljšanje odobritve aktivnih snovi,
- pregled odobritve aktivnih snovi,
- predložitev vlog za vključitev v Prilogo I aktivnih snovi, ki izpolnjujejo pogoje iz člena 28 in pregled vključitve takšnih aktivnih snovi v Prilogo I
- določitev možnih aktivnih snovi za zamenjavo
- predložitev vlog za dovoljenje Unije za biocidne proizvode ter za podaljšanje, preklic in spremembo dovoljenj Unije, razen v primeru vlog za upravne spremembe
- znanstvene in tehnične zadeve v zvezi z medsebojnim priznavanjem v skladu s členom 38,
- na zahtevo Komisije ali držav članic je BPC odgovoren tudi za pripravo mnenja o vseh drugih vprašanjih, ki izhajajo iz izvajanja uredbe BPR v zvezi s tehničnimi smernicami ali tveganji za zdravje človeka, zdravje živali ali okolje.
Sestava
Vsaka država članica je upravičena do imenovanja enega člana v Odbor za biocidne proizvode za triletni mandat, ki je obnovljiv. Države članice lahko imenujejo tudi njegovega namestnika.
Vlagatelji lahko sodelujejo v razpravah BPC. Dnevni red za sestanke BPC se objavi najkasneje 21 dni pred sestankom. Če želijo vlagatelji sodelovati pri obravnavi svoje točke na dnevnem redu, morajo stopiti v stik s sekretariatom Odbora za biocidne proizvode (BPC (na) echa.europa.eu) in zlasti slediti pristopu, ki je opisan v oddelku 3 Kodeksa za vlagatelje, ki sodelujejo v BPC in njegovih delovnih skupinah.
Committee's activities
- List of BPC members with their CVs and Declarations of interest
- Meetings (dates, agendas and minutes)
- Rules of procedure of the BPC [PDF]
- Rules for accessing S-CIRCABC interest groups
- List of Accredited Stakeholder Organisations [PDF]
- Code of Conduct for applicants participating in the BPC and its Working Groups [PDF]
- Work programme for BPC 2024 for active substance approvals [PDF]
BPC Opinions
Working procedures
- E-consultations and early Working Group discussions [PDF]
- Working procedure for opinions on technical and scientific matters concerning mutual recognition [PDF]
- Framework for requests according to Article 75 (1)(g) of the BPR [PDF]
- New information in active substance and Union authorisation opinion forming [PDF]
- Working procedure for active substance approval and renewal [PDF] (applicable from 5 March 2024)
- Validation PBT and ED status
- ED assessment for active substances where the CAR was submitted before entry into force of the BPR: literature review [PDF]
- Principles for the assessment of endocrine disrupting properties in active substance approval [PDF]
- Timelines for the opinion-forming of AS applications [PDF]
- Applicability of new guidance and guidance-related documents [PDF]
- Procedure for redefinition of an active substance according to Article 13 of Regulation (EU) No 1062/2014 [PDF]
- Procedure for the submission, evaluation and dissemination of data generated after active substance approval [PDF]
- Note for eCA's on how to act in case an applicant in the Review Programme does not provide in time information requested during the evaluation phase [PDF]
- Working procedure for Union authorisation application (22/03/2024) [PDF]
- Timelines for the opinion-forming of Union Authorisation applications
- Linguistic review of SPC translations for Union authorisation and for major changes applications of Union authorisation (05/12/2023) [PDF]
- Post-authorisation conditions for Union authorisation [PDF]
- Guiding principles on providing data during Union Authorisation process (31/01/2024) [PDF]
- Working Procedure for major changes application of a Union Authorisation (22/03/2024) [PDF]
- Working procedure for minor changes application of a Union authorisation (22/03/2024) [PDF]
- Union authorisation application of same biocidal products