Harmonised practices
The way in which the Ctgb assesses BPR applications is increasingly being determined and harmonised at the EU level. The European Chemicals Agency (ECHA) in Helsinki is responsible for establishing the vast majority of European assessment practices. The EU member states also contribute to this process.
The agreed practices are mainly laid down in Guidance Documents Volume I through V. Supplementary practices specifically for the environment are included in Emission Scenario Documents (ESD) and calculation sheets. Only the Guidance Documents Volume I through V have official status; the ESDs and spreadsheets are considered by ECHA as advisory documents. The final adoption of harmonised assessment practices is done by ECHA itself, after consultation with third parties in Partner Expert Groups (PEGs).
In addition to specific content, procedural agreements are also adopted. The latter often originate from the Coordination Group (CG) or from meetings of the European Member States Competent Authorities (CA).
Working Groups
However, the current assessment practices sometimes leave room for interpretation or are not yet sufficiently specified for certain topics. The Biocidal Products Committee (BPC) Working Groups have been established to ensure that member states, wherever possible, conduct assessments in the same way and pursue the same level of protection. These Working Groups provide technical input to devise suitable solutions for gaps and ambiguities.
The proposals made by the Working Groups are adopted by the BPC.
TAB agreements
Agreements on legal instructions for use (WG) are published in the document Technical Agreements for Biocides (TAB agreements). Many TAB agreements will be included in other documents at a later date, for example in an update of the Guidance Documents, a calculation sheet or an ESD.
When do various documents go into force?
- Harmonised assessment practices from the CG or the CA: on the date of the CircABC publication if publicly available and otherwise immediately;
- New ECHA Guidance Documents (Volumes): immediately unless new data is required; in that case after six months for substances or after two years for products. Always version 1.0;
- ECHA guidance updates (Volumes): on the date of publication plus six months for substance guidance, or plus two years for product guidance. Example: from version 2.4 to 3.0;
- Advisory documents such as ESDs, calculation sheets or new forms: on the date of publication if publicly available and otherwise immediately;
- TAB agreements: on the date of publication unless new data is required.