Guidance documents

Guidance on the implementation of Directive 98/8/EC

One of the initiatives, undertaken by the Commission together with the Member States, for setting up the frame for the evaluation and entry of the active substances onto Annex I (or IA or IB) was to ensure that guidance is available for industry and the Competent Authorities to fulfil their requirements under the BPD.
Some guidance, mainly related to scope, is available on the web site of the European Commission, Directorate-General for Environment.
Guidance development can be initiated by Member States or the Commission or be identified at the Competent Authority meeting or the Technical Meeting.
A Procedure on guidance development, including rules for endorsement, consultation and entry into force, is also available, together with Guidance documents released for consultation (by Directorate-General for Environment).

Technical Notes for Guidance (TNsG)

Six Technical Notes for Guidance (TNsG) have specifically been developed for biocides:

1. TNsG on Data Requirements

The TNsG on Data Requirements document provides guidance on the data requirements and waiving arguments that are required for biocidal active substances and products.
Addendums are available for

• Rodenticides (PT 14),
• Insecticides (PT 18), oils and extracts (PT 19), 
• Naturally occurring substances (PT 19),
• Pheromones (PT 19),

• Micro-organisms including viruses and fungi,
• Analytical methods.
  
  

2. TNsG on Annex I Inclusion

The TNsG on Annex I Inclusion document identifies criteria for unacceptable/acceptable effects and associated conditions for inclusion of active substances onto Annex I (or IA or IB). A revised Chapter 10 on "Resistance" and a revised Chapter 4.1 on "Quantitative Human Health Risk Characterization" are available.

3. TNsG on Product Evaluation

The TNsG on Product Evaluation document provides guidance on how to perform the administrative and scientific evaluation of applications for authorisation and registration. A revised appendix to chapter 7 on efficacy of rodenticides and a revised Chapter 6.2 on resistance, both from 2009, are available.

4. TNsG on Human Exposure

The TNsG on Human Exposure document (2007 *) provides guidance on the estimation of Human Exposure to biocidal products for all Product Types.
The first version of this TNsG is from 2000. This 2000 version was revised two times.
The most recent version is of 2008 (which includes an Excel file containing default exposure data for all PTs). An addendum on how to obtain BEAT including a password and a corrigendum for PT 21 are available.
An earlier version is available: 2002 ( Foreword and Summary,  Part I,  Part II).
Guidance on the use of the human exposure guidance for the Review Programme and the peer-review of new active substances is also available.
In 2007 the Human Exposure Expert Group (HEEG) was established. This group discusses issues that arise during discussions on active substances during the evaluation process, as well as issues on methodology and needs for update of guidance documents:   Opinions of the HEEG endorsed by the TM.
A workshop on Human Exposure to Biocides took place in Oslo on 24-26 February 2009, including three sessions: health and safety during the use of biocidal products, occupational exposure assessment for biocidal products using BEAT, consumer exposure assessment for biocidal products using ConsExpo. See also the   Training material.

5. TNsG on Dossier Preparation and Study Evaluation

The TNsG on Dossier Preparation and Study Evaluation guidance focuses primarily on applications for the inclusion of active substances onto Annex I (or IA or IB). It is intended to give guidance on how the documentation to be submitted by the applicant should be prepared and presented.

The TNsG is available in 3 parts as:

• Part I
• Part II
• Part III -  also available in Word format:  Part III (1; 2; 3; 4; 5; 6)

The following additional information is available:

• Application codes for PT 08, PT 14, PT 18, 19 e 20;
• Standardised tables to present the risk characterisation for human health.
  
  

6. TNsG on the assessment of technical equivalence

The TNsG on the assessment of technical equivalence guidance is intended to establish harmonised criteria and processes for assessing the equivalence of different sources of a substance versus the reference source.

Additional guidance on specific issues

The TNsGs have assured that there is a common understanding of the obligations under the BPD. For specific issues there has been a need to further develop subsections of these guidance documents, which are provided below:

• Guidance on the relevance of the manufacturing process when carrying out the risk assessment under the BPD;
• Guidance on the product dossier for Annex I inclusion of an active substance;
• Guidance on how to treat degradation and sorption data for groundwater assessment;
• Guidance on rapidly degrading substances;
• Guidance on the use of a plant protection products monograph and existing substances risk assessment reports under the BPD;
• Guidance on risk characterisation of local effects in the absence of systemic effects;
• Guidance on the relevance of REACH guidance for dossier evaluation under the BPD;
• Guidance on leaching rate estimation for PT 07, 09 and 10;
• Guidance on the role of efficacy in the evaluation of active substances for Annex I inclusion.

Technical Guidance Document (TGD)

The EU Technical Guidance Document (TGD) for risk assessment of new and existing substances and biocides is the basis for risk assessment of active substances.

Guidance Related Legislation and Organizations

The following technical guidance developed under regulatory frameworks is of relevance for biocides:

• For plant protection products: technical guidance from EFSA and DG SANCO.
• For industrial chemicals: technical guidance from ECHA.
• For veterinary medicines: technical guidance from EMEA.
• Biocide Programme from OECD.
• Regulating Antimicrobial Pesticides from U.S. EPA.

* This document replaces the TNsG on Human Exposure to Biocidal Products from June 2002 including the User Guidance Version 1. This is the same document that has earlier been available on the JRC website with the date “January 2008”. This was changed in September 2009 because the date of endorsement was in fact in June 2007. This document was endorsed at the 25th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (19-21 June 2007).