Services

EU

 

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.

 

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:

 

  • Preparation of active substance approvals and biocidal product authorisations

  • Development of Biocidal Product Families, meta-SPC and authorisation strategies

  • Risk assessment

  • Development of Authorisation strategies and planning

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

  • Planning of test programmes, including efficacy testing

  • Renewals of active substance approvals and biocidal product authorisations, including Comparative Assessment

  • Technical Equivalence Applications

  • EU Representative services

  • Obtaining Article 95 status including EU Representative service

  • Consortia management

  • Labelling and reporting requirements for treated articles

  • Post-approval support and asset management

  • Socio-economic analysis (SEA) for comparative assessment

  • Independent expert witness/representative at BPC/Working Group Meetings

  • Negotiations with Authorities

  • National registration of biocidal products

  • Project management and study monitoring

  • CLP classification of substances and products

  • (Q)SAR and classification of products using calculation methods

  • Advice on scope in relation to REACH and other legislation

  • 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 now for information on how we can help you.

Arrow Regulatory Limited

6th Floor, City Gate East

Toll House 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

Tirol

AUSTRIA


T:  +43 (0) 660 1162392   

© 2020 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 529749. Registered Office: Grabenweg 68, 6020 Innsbruck, Tirol, Austria