Chemistry Reference
In-Depth Information
consideration as low-risk active substances;
identification as candidates for substitution;
decisions on the interim criteria for endocrine disrupting properties that may cause
adverse effects in humans;
decisions on the relevance of metabolites that can occur in groundwater;
decisions on toxicity with regard to defined persistence, bioaccumulation and toxicity
(PBT) properties;
setting risk mitigation measures for operators, workers, bystanders and residents in the
procedure of national authorization of PPPs.
Therefore, a finalized harmonized C&L for active substances is, in many cases, a
prerequisite for the harmonized authorization of PPP and mutual recognition according to
the PPP Regulation. Furthermore, a final classification and labelling of the active substance
is also essential for comparable decisions on approval of active substances in plant
protection products under the PPP Regulation and biocidal products under the new Biocidal
Products Regulation which will be published in 2012. Although the new Biocidal Products
Regulation was not the subject of the workshop, part of the workshop results could have a
positive impact on the classification procedure of biocides since the new Regulation will
include cut-off criteria comparable to the PPP Regulation.
2. Workshop results
The main objectives of the workshop were to discuss options on how the two processes can
most efficiently be aligned at the level of Member State authorities, EFSA and ECHA in the
plenary session and in two main breakout group topics:
i.
streamlining and integration of the review procedures for active substances in PPP for
approval under the PPP Regulation and for classification and labelling under the CLP
Regulation.
ii.
scientific and practical issues in the interpretation of carcinogenicity, mutagenicity and
reproductive toxicity studies and reporting regarding the criteria and practicalities in
preparation of dossiers under both legislative frameworks.
The workshop started with a plenary session with lectures to introduce the two regulatory
frameworks and provide technical information on the individual processes before entering
into detailed discussions in two breakout groups. The presentations given in this first
plenary session are available in Annex III of the workshop report which is published on the
European Commission website:
(http://ec.europa.eu/food/plant/protection/evaluation/docs/report_berlin_april2011_en.pdf).
3. Streamlining and integration of the review procedures
Before the workshop, EFSA and ECHA had already started an exchange of information in
order to identify practical solutions for processing proposals for CLH (especially for the
