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New Criteria for Environmental Hazard Classification under the CLP Regulation (2nd ATP) - Comparative Exercise

This comparative exercise examines the application of new criteria for environmental hazard classification under the CLP Regulation. The exercise evaluates the impact of these criteria on a small set of substances, including pesticides, biocides, and industrial substances registered under REACH.

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New Criteria for Environmental Hazard Classification under the CLP Regulation (2nd ATP) - Comparative Exercise

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  1. New criteria for environmental hazard classification under the CLP Regulation (2nd ATP) - Comparative exercise -

  2. Background • The CLP Regulation (EC) N°1272/2008 (European Commission, 2008) included criteria for classification of long-term environmental hazard of substances (i.e. Category Chronic 1 to 4) based on acute aquatic toxicity data (along with information on ready degradability and bioaccumulation potential). The Commission Regulation (EU) N°286/2011 (2nd ATP) amended the criteria and introduced the requirement for applicants to use chronic aquatic toxicity data to classify the long-term environmental hazard of a substance, when available. The new criteria apply to substances from the 1st December 2012. • After the 10th meeting of the Competent Authorities for REACH and CLP (CARACAL) (21-23 March 2012) where the need for an initial screening of the number of substances affected and consequent prioritisation has been emphasized, at the 12th (CARACAL) meeting COM informed that it was ready to take the lead on the screening of Annex VI substances classified for environmental hazard in collaboration with JRC-IHCP. • Objectives • Taking into account the suggestions from the 10th CARACAL meeting and the need for an initial screening of the substances before making a decision on whether or not to perform this task, JRC-IHCP was required to: • Carry out a comparative exercise on a small set of substances (including pesticides, biocides, and industrial substances registered under REACH) by applying 'initial' (CLP Regulation (EC) N°1272/2008) and 'new' criteria (EU) N°286/2011 (2nd ATP) for environmental long-term hazard classification to acute and chronic aquatic toxicity data that are publicly available

  3. Method • The comparative exercise was carried out on a small set of 15 substances: • Five active substances used in Plant Protection Products (PPP) • Five active substances used in Biocidal Products (BP) • Five industrial substances currently registered under REACH Regulation and previously registered as 'new substances' under the Dangerous Substances Directive (DSD) (67/548/EEC) • The data used for the comparative exercise (acute and chronic toxicity data, biodegradation and bioaccumulation potential) were retrieved from the following sources: • EFSA Conclusions regarding the peer review of the risk assessment of the five active substances used in PPPs (Plant Protection Products) http://www.efsa.europa.eu/en/pesticides/pesticidesscdocs.htm?scdtype=conclusion • Assessment Reports of the five active substances used in BP (Biocidal Products) • http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances • ECHA Database of Registered Substances for the five industrial substances • http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances • Each substance has been classified according to both initial criteria and new. The initial criteria have been applied to acute aquatic toxicity data, while the new criteria have been applied to the chronic aquatic toxicity data referring to three trophic levels, if available. If not, the acute dataset was used according to the procedure reported in Commission Regulation (EU) N°286/2011 (2nd ATP). The lowest acute and/or chronic data have been used to determine the final classifications both in the case of the initial and new criteria. 3

  4. Results • For two biocides only acute data were available and therefore these two substances have not been considered in the overall results, reducing the dataset to 13 substances, as the classification would not change. • Taking into account the small number of substances the results should be considered as merely indicative. • Overall, 8 substances out of 13 undergo a variation which can be related to the classification and/or to the M factor • In three cases the classification becomes stricter: • one pesticide and one biocide move from Category Chronic 3 to 2 • one industrial substance moves from Category Chronic 2 to 1 • For two industrial substances the classification becomes less strict: • one substance moves from Chronic Category 1 to 2 • one from Chronic Category 3 to 4 • In two cases the M factor becomes stricter: • two pesticides move from 10 to 100 • one industrial substance does not need the M factor based on 2008 criteria as it is classified as Chronic Category 2 but needs a M factor of 1 based on new criteria as it moves to Chronic Category 1. • In two cases the M factor becomes less strict: • one biocide moves from 10 to 1; • one REACH substance has an M factor of 1 based on 2008 criteria but does not need it according to new criteria, as it moves from Chronic Category 1 to Chronic Category 2. 4

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