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Guidance documents

Guidance and other relevant documents on the implementation of Directive 98/8/EC

 

On 1st September 2013 the Biocides Products Regulation will enter into operation and ECHA takes over the regulatory management of biocides. From that date onwards ECHA makes related Guidance Documents available through its website.

The Guidance in support of the BPD originally published on this JRC page has also been moved to the ECHA website.

Under the Biocidal Products Regulation the development of Guidance Documents for the implementation of the Biocides Products Regulation is managed by ECHA

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 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 should be utilised notwithstanding the references to the BPD and without prejudice to the scientific content. 

The Human Exposure Expert Group (HEEG) was established in 2007 under the BPD to discuss 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 Technical Meeting. Since the beginning of 2014, the HEEG opinions are published on the ECHA website. 

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.

 

 

 

 

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