Biocidinių produktų komitetas
Biocidinių produktų komitetas
Biocidinių produktų komitetas (BPK) rengia ECHA nuomones dėl kelių BPR procedūrų. Galutinius sprendimus priima Europos Komisija. Šios procedūros yra:
- paraiškos patvirtinti veikliąsias medžiagas arba pratęsti patvirtinimo galiojimą;
- veikliųjų medžiagų patvirtinimo peržiūra;
- paraiškos įrašyti 28 straipsnyje nustatytas sąlygas atitinkančias veikliąsias medžiagas į I priedą ir paraiškos peržiūrėti tokių veikliųjų medžiagų įrašymą į I priedą;
- keistinų veikliųjų biocidinių medžiagų nustatymas;
- paraiškos išduoti biocidinių produktų Sąjungos autorizacijos liudijimą, pratęsti Sąjungos autorizacijos liudijimų galiojimą, juos panaikinti ir iš dalies keisti, išskyrus atvejus, kai paraiškos susijusios su administracinio pobūdžio pakeitimais;
- pagal 38 straipsnį su abipusio pripažinimo principu susiję moksliniai ir techniniai klausimai;
- Komisijos ar valstybių narių prašymu BPK taip pat yra atsakingas už nuomonės rengimą visais kitais su rizika žmonių ir gyvūnų sveikatai ar aplinkai arba su techniniais nurodymais susijusiais klausimais, kylančiais įgyvendinant BPR.
Sudėtis
Kiekviena valstybė narė turi teisę į BPK paskirti vieną narį, kurio kadencija gali būti pratęsta trejiems metams. Jos taip pat gali paskirti pakaitinį narį.
Pareiškėjai gali dalyvauti BPK diskusijose. BPK posėdžių darbotvarkė paskelbiama ne vėliau kaip 21 dieną iki posėdžio. Jeigu pareiškėjai pageidauja dalyvauti svarstant jiems skirtą darbotvarkės punktą, jie turėtų kreiptis į BPK sekretoriatą (BPC (@) echa.europa.eu) ir visų pirma laikytis BPK ir jo darbo grupių posėdžiuose dalyvaujančių pareiškėjų elgesio kodekso 3 skirsnyje aprašytos tvarkos.
Committee's activities
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 8 October 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
- 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 (26/06/2024) [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 (09/10/2024) [PDF]
- Post-authorisation conditions for Union authorisation [PDF]
- Guiding principles on providing data during Union Authorisation process (31/01/2024) [PDF]
- Working procedure for renewal of a Union authorisation (09/10/2024) [PDF]
- Guidelines for applicants on submission of applications of renewal of a Union authorisations (09/10/2024) [PDF]
- Criteria to choose full evaluation in the context of renewal of a Union authorisation (09/10/2024) [PDF]
- Linguistic review of the translations of the summary of product characteristics (SPC) for renewal of a Union authorisation (09/10/2024) [PDF]
- Working Procedure for major changes application of a Union Authorisation (26/06/2024) [PDF]
- Working procedure for minor changes application of a Union authorisation (26/06/2024) [PDF]
- Union authorisation application of same biocidal products
- 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 8 October 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
- 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 (26/06/2024) [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 (09/10/2024) [PDF]
- Post-authorisation conditions for Union authorisation [PDF]
- Guiding principles on providing data during Union Authorisation process (31/01/2024) [PDF]
- Working procedure for renewal of a Union authorisation (09/10/2024) [PDF]
- Guidelines for applicants on submission of applications of renewal of a Union authorisations (09/10/2024) [PDF]
- Criteria to choose full evaluation in the context of renewal of a Union authorisation (09/10/2024) [PDF]
- Linguistic review of the translations of the summary of product characteristics (SPC) for renewal of a Union authorisation (09/10/2024) [PDF]
- Working Procedure for major changes application of a Union Authorisation (26/06/2024) [PDF]
- Working procedure for minor changes application of a Union authorisation (26/06/2024) [PDF]
- Union authorisation application of same biocidal products