Sectors

Biocides

European Union

 

Regulation of biocidal products was first introduced in 2000 to harmonise the data requirements and evaluation procedure for both active substances and biocidal products across the EU. The resulting Biocidal Products Regulation (EU) No 528/2012 (BPR) is now considered worldwide to be the most demanding piece of legislation applicable to biocidal products.

 

A major feature of the Regulation has been to make it more inclusive with more active substances and products falling within the scope of the Regulation than ever before. Whether you market an active substance, a biocidal product, a machine that can generate an active substance, a precursor that could be used to generate an active substance an article that has been treated with a biocidal product or simply make a claim that is considered biocidal, you could have obligations under the BPR. The burden of complying with the Regulation firmly rests with industry.

Arrow Regulatory's expert team can help you understand what your obligations are and provide cost effective solutions for compliance.

 

Great Britain

 

As of 1 January 2021, biocidal products in Great Britain (Scotland, Wales and England) are regulated under the GB regulatory framework for Biocidal Products Regulations and CLP; Statutory Instrument 2019, No 720. The GB Regulation mirrors that of the EU BPR with regard to the active substance approvals and product authorisation requirements. Deviation from the EU BPR lies in the authorising body for active substances, active substances supported in GB and whether co-formulants are supported under UK-REACH.

 

Arrow Regulatory's expert team can help you understand what your new GB obligations are and the implications for existing products already on the GB market.

World Wide Markets

 

There is no global harmonisation of biocidal product regulation with many countries recognising biocidal products as a distinct chemical category. Arrow Regulatory has a network of global contacts to help you negotiate the regulatory maze that exists outside the EU.

Our services:

Key services

  • Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensation

  • Regulatory strategy development

  • CLP classification of substances and products

  • Project management and study monitoring

  • Preparation of IUCLID dossiers

  • Risk assessment

  • Poison Centre Applications

  • EU Representative services 

  • GB Representative services

  • Consortia management 

​Related services

  • 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 

  • Post-approval support and asset management

  • Global product compliance

Our expertise:

 

The unique expertise of Arrow Regulatory's consultants includes over 18 years working on EU Regulation of biocides and involvement in the preparation of over 30 active substance inclusion dossiers, including in-situ generation systems and Annex I substances. We work with major producers to achieve Union authorisation or National authorisation with Mutual Recognition for their products.  Our wide experience in supporting active substances and biocidal products is your guarantee of a quality expert service.

Contact us for information on how we can help you.

Arrow Regulatory Limited

6th Floor, East West Building

2 Tollhouse Hill

Nottingham NG1 5FS

UNITED KINGDOM
 

T: +44 (0) 115 9352243

Arrow Regulatory (Ireland) Limited

9 Pembroke Street Upper
Dublin 2

D02 KR83

IRELAND


T:  +353 (0) 1 653 2165

Arrow Regulatory GmbH

Grabenweg 68

6020 Innsbruck

Tyrol

AUSTRIA


T:  +43 (0) 660 1162392   

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© 2021 Arrow Regulatory

Arrow Regulatory Limited is a company registered in England and Wales with company number 10171397. Registered Office: 149-155 Canal Street, Nottingham,  NG1 7HR, UK

Arrow Regulatory (Ireland) Limited is a company registered in Ireland with company number 614017. Registered Office: The Black Church, St Mary's Place, Dublin 7, D07 P4AX, Ireland

Arrow Regulatory GmbH is a company registered in Austria with a company number FN 529473m. Registered Office: Grabenweg 68, 6020 Innsbruck, Tyrol, Austria  [Impressum]