Guidance and other relevant documents on the implementation of Directive 98/8/EC
Technical Notes for Guidance (TNsG) and other technical guidance documents were developed for the implementation of the Biocidal Products Directive 98/8/EC (BPD) to enable industry and competent authorities to fulfil their requirements under the BPD. The JRC- Biocides website – where these documents have been located was duplicated below with some amendments. Some guidance, mainly related to the scope of the BPD, is available on the website of the European Commission, Directorate-General for Environment. In addition to these guidance documents, the Manual of Technical Agreements containing agreements of the Biocides Technical Meetings, the EU Evaluation Manual for the Authorisation of Biocidal Products and Manual of Decisions (maintained by the Commission) containing questions and answers of general interest in particular on borderline cases between the BPD and other Directives provide further clarifications on certain aspects in relation to the BPD's implementation.
Furthermore, documents and IT tools like the Emission Scenario Documents (ESDs) and the European Union System for the Evaluation of Substances (EUSES) are fundamental for biocides risk assessment. The section below lists all the documents specifically developed for biocides under the BPD, whereas a link to EUSES is provided.
Applications for active substances for Annex I inclusion under the BPD (Review Programme for existing active substances and Article 11 of the BPD for new active substances) or applications for product authorisation under the BPD may still be under evaluation when the BPR comes into application on 1 September 2013. Therefore, the relevant guidance together with other relevant documents mentioned above prepared under the BPD may still need to be consulted during the evaluation of these applications.
Until all guidance in support of the BPR is made available on the ECHA website the relevant BPD Guidance and related documents are recommended to be followed. In such cases, the BPD Guidance and related documents listed below should be utilised notwithstanding the references to the BPD and without prejudice to the scientific content.
A revised appendix to chapter 7 on efficacy of rodenticides and a revised Chapter 6.2 on resistance, both from 2009, are available and more recently on the efficacy of insecticides, acaricides and products to control other arthropods (PT 18) and repellents and attractants (PT19) (only concerning arthropods) are available.
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 ( Technical Notes for Guidance - Human Exposure to Biocidal Products - Guidance on Exposure Estimation - In four parts: Foreword and summary - Part 1 - Part 2 - Part 3), as well as User Guidance - Version 1 - Human Exposure to Biocidal Producst (TNsG June 2002).
A Guidance on the use of the human exposure guidance for the Review Programme and the peer-review of new active substances (2009) 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.
- TNsG on Human Exposure document [PDF]
- Excel file containing default exposure data for all PTs [XLS]
- Addendum on how to obtain BEAT including a password [DOC]
- corrigendum for PT 21 [PDF]
- Technical Notes for Guidance - Human Exposure to Biocidal Products - Guidance on Exposure Estimation - In four parts: Foreword and summary - Part 1 - Part 2 - Part 3 [PDF]
- User Guidance - Version 1 - Human Exposure to Biocidal Producst (TNsG June 2002) [PDF]
- Guidance on the use of the human exposure guidance for the Review Programme and the peer-review of new active substances (2009) [PDF]
- Opinions of the HEEG endorsed by the TM.
- Training material
The TNsG is available in 3 parts as:
- 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 [PDF]
- Guidance on how to treat degradation and sorption data for groundwater assessment [PDF]
- Guidance on rapidly degrading substances [PDF]
- Guidance on the use of a plant protection products monograph and existing substances risk assessment reports under the BPD [PDF]
- Guidance on risk characterisation of local effects in the absence of systemic effects [PDF]
- Guidance on the relevance of REACH guidance for dossier evaluation under the BPD [PDF]
- Guidance on leaching rate estimation for PT 07, 09 and 10 [PDF]
- Guidance on the role of efficacy in the evaluation of active substances for Annex I inclusion [PDF]
- JRC website
- European Commission, Directorate-General for Environment
- Manual of Technical Agreements
- EU Evaluation Manual for the Authorisation of Biocidal Products
- Manual of Decisions maintained by the Commission
- Emission Scenario Documents (ESDs)
- The European Union System for the Evaluation of Substances (EUSES)