Direttiva relativa ai biocidi

Direttiva relativa ai biocidi

Direttiva relativa ai biocidi

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.   

 
1. TNsG on Data Requirements
The TNsG on Data Requirements documentprovides guidance on the data requirements and waiving arguments that are required for biocidal active substances and products.

Addendums are available for

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 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.

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 ( 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.

* 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).
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. Note that from 1 September 2013, applications are to be submitted exclusively via R4BP and the dossier must be compiled using the IUCLID software package. The relevant manuals and templates are available at http://echa.europa.eu/echa.europa.eu/support/dossier-submission-tools/r4bp.

The TNsG is available in 3 parts as:

The following additional information is available:

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.

7. 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.

  • Part I [PDF], General Introduction & Risk Assessment for Human Health
  • Part II [PDF], Environmental Risk Assessment
  • Part III [PDF], Use of (Quantitative) Structure Activity Relationships ((Q)SARs), Use Categories, Risk Assessment Report Format
  • Part IV [PDF], Emission Scenario Documents
8. Manual of Technical Agreements (MOTA)
The Manual of Technical Agreements (MOTA) (Version 5, 2013) contains the agreements of the Biocides Technical Meetings (TM) in a concise format. It focuses on methodological and procedural agreements that have been reached in the TMs. MOTA is not a legally binding document, but is intended to provide a source of information on the TM agreements with general relevance.

 
 
9. ESDs
Emission scenario documents (ESDs) are used to estimate the initial release of substances from biocidal products (or treated materials) to the environment per PT.

10. EU Evaluation Manual for the Authorisation of Biocidal Products

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