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Toxicology - Classification and Labelling

Classification of pesticide active substances and plant protection products must be performed in accordance with Regulation (EC) 1272/2008 (CLP Regulation).  Further information is available in: Introduction to Classification and Labelling.

The following subsections are included on this page:

Classification by Calculation

The reduction of vertebrate testing is a requirement under Regulation 1107/2009. Before initiating any experimental testing, consideration should be given to using the calculation method to determine the classification in accordance with Regulation EC 1272/2008.

The calculation method allows for mixtures of chemicals(such as plant protection products) to be classified for human health effects in accordance with Regulation (EC) 1272/2008, without conducting any toxicology testing.  The method relies upon toxicological data on the components of the mixture, predominantly taken from appropriate Safety Data Sheets (SDS).

HSE's Chemicals Regulation Division (CRD) expects the calculation method to be used wherever feasible and where a reliable conclusion can be reached. CRD will use this method in preference to the evaluation of any toxicology studies.

The guidance document on the application of CLP contains information on the calculation method, and is available via the ECHA CLP Guidance page

Special Labelling Requirements for Sensitisers

In accordance with the 4th ATP to Regulation (EC) 1272/2008: to be applied from 1 December 2014 for substances, and 1 June 2015 for mixtures:

Special labelling may be required for mixtures which contain substances classified as respiratory or skin sensitisers, even if present in a mixture at levels below the appropriate concentration limit for the classification of a mixture, and/or where experimental testing produced a negative result.

The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than that specified in table 3.4.6 of Annex I of Regulation (EC) 1272/2008 shall bear the following statement:

EUH208 – 'Contains (name of sensitising substance). May produce an allergic reaction.'

For sensitising substances with a specific concentration limit lower than 0.1% (w/w), the concentration limit for elicitation of the special labelling requirement is set at one-tenth of the relevant specific concentration limit.

Potent Sensitisers and In-Use Dilutions

Where a formulated plant protection product (PPP) is classified for skin sensitisation in accordance with CLP (Regulation (EC) 1272/2008), its use must not present a risk to bystanders.  This requires that for a product classified in category 1/1B the lowest in-use dilution (most concentrated) must be <1% (1:100). For a product classified in category 1A, the lowest in-use dilution (most concentrated) must be <0.1% (1:1000).

Alternatively, experimental data which determines an EC value of <3 at the lowest (most concentrated) in use dilution may be sufficient to demonstrate that there is no risk to bystanders.

Updated 2016-12-01