Biocides – Registration / Authorisation

Biocides – Registration / Authorisation
Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensationRegulatory strategy developmentProject management and study monitoringCLP classification of substances and productsPreparation of IUCLID dossiersOECD Harmonised TemplatesRisk assessmentPoison Centre NotificationsSelling chemical products onlineRegulatory submissions

 

Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.

• Ekotox Centers
• 
• Tel +421 2 45943712
• e-mail on ekotox(at)ekotox.eu

We offer support and preparation of all documents. Required for registration / authorisation of a biocidal product for placing on the market in EU member states.

For example complex services for registration under transitional period or authorisation once the active substance is approved:

• Documents preparation including relevant forms and processes
• Efficacy assessment
• R4BP / IUCLID / SPC
• Biocidal product entry in the Register of EU MS or EU wide
• Material Safety Data Sheet (MSDS)
• Text part of the label
• Instructions for use, if not stated on the label

Application types Article 95: List of active substances and suppliersTechnical equivalenceIn situ generated active substancesTreated articlesRegistration/notification of biocidal products under transitional provisions

 

 Understanding Biocidal Products Regulation

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) provides a regulatory framework for biocidal products placed on the European Union market. The BPR entered into force in September 2013 and replaced the Biocidal Products Directive (Directive 98/8/EC). 

 The biocidal product requires an authorisation at national or EU level before it can be made available on the market or used. 

 Access to the market is based on a two-step procedure: 

• The active substance to be used in a biocidal product or to treat an article must be approved (assessed positively for its efficacy and safety in the relevant product type). 

• After the active substance has been authorised as per step 1, biocidal products that contain the active substance can be authorised in an approval procedure. 

 If the active substance is not yet approved but is in the Review Programme, the biocidal product can be made available and used in accordance with national laws (transitional provisions). 

Our services: 

Key services

Related services

Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensation  Regulatory strategy development  Project management and study monitoring  CLP classification of substances and products  Preparation of IUCLID dossiers  Risk assessment  Poison Centre Notifications  EU Representative services   Consortia management

Preparation of active substance approvals and biocidal product authorisations (BPR and Transitional Arrangements)   Development of Biocidal Product Families  Development of Authorisation strategies   Planning of test programmes, including efficacy testing  Technical Equivalence Applications  Obtaining Article 95 status   Renewals of active substance approvals and biocidal product authorisations, including Comparative Assessment  Product Label Reviews   Advice on treated article status and labelling   Regulatory submissions and post-approval support and asset management

Companies wishing to place biocidal products on the market can apply for product authorisation at National or Union level under the following application types:

• National Authorisation
• Mutual Recognition
• Union Authorisation
• Simplified Authorisation
• Biocidal Product Families
• Parallel Trade Permits
• Same Biocidal Products

Registration of biocidal products under transitional provisions in Slovakia

 

Contact us now for more information

---

You can browse all of our biocides training.