Toxicology - Classification and Labelling
Pesticide active substances and formulated plant protection products (PPPs) must be classified and labelled in accordance with Regulation (EC) 1272/2008 (GB/NI CLP). Further information is available in: Introduction to Classification and Labelling.
This page contains important information on some aspects of the classification and labelling of pesticide active substances and formulated plant protection products for human health toxicological hazards.
The following subsections are included on this page:
- Calculation Method of GB/NI CLP for mixtures
- Special Labelling for Sensitisers
- Potent Skin Sensitisers and In Use Dilutions
Calculation Method of GB/NI CLP for mixtures
Regulation (EC) 1107/2009 applied from 14 June 2011 and lays down a number of requirements aimed at avoiding unnecessary testing on vertebrate animals, where alternative methods are available.
The calculation method of Regulation (EC) 1272/2008 (GB/NI CLP) may be used as an alternative method for fulfilling the toxicological data requirements for PPPs as described in section 7.1 of Regulation (EC) 284/2013 (acute toxicity, skin irritation, eye irritation and skin sensitisation) and for the human health hazard classification of the formulation for these properties and other potential hazards.
As an acceptable alternative method to whole formulation in vivo testing, consideration of the application of the calculation method should always be made in advance of any formulation testing in vertebrate animals for the previously stated toxicological properties. HSE will not accept information from formulation studies conducted in vertebrate animals after the entry into force of Regulation (EC) 1107/2009 (June 2011) where the calculation method (or other validated alternative method) could have reliably been used.
For the classification of formulated PPPs for all other human health hazards (eg specific target organ toxicity, carcinogenicity, mutagenicity, reproductive toxicity) the calculation method of GB/NI CLP must always be used, unless specific formulation data leading to a more severe classification are available.
The calculation method allows for mixtures of chemicals (such as PPPs) to be classified for human health hazards in accordance with GB/NI CLP, without conducting any specific toxicology testing. The calculation method utilises information on the toxicity and classification of the components of a mixture to conclude on the overall toxicological hazard and classification of the mixture. For the assessment of PPPs, this information is predominantly taken from valid Safety Data Sheets (SDS), but information from other reliable sources may be used where appropriate.
The guidance document on the application of GB/NI CLP contains information on the application of the calculation method.
For skin sensitisation, HSE requires, in general, reliable information (for example, experimental data) on the skin sensitisation potential of all components in the mixture for a negative classification (using the calculation method) to be acceptable.
Special Labelling Requirements for Sensitisers
In accordance with GB/NI CLP, special labelling provisions may be applicable to mixtures that contain substances classified as skin or respiratory sensitisers. These specific labelling provisions apply to mixtures containing one or more sensitising components at levels below the appropriate concentration limit for the classification of that mixture in accordance with the calculation method of GB/NI CLP and/or where formulation testing determined that the conditions for classification were not met.
Mixtures that do not meet the criteria for classification for sensitisation, but which contain one or more sensitising components present at a concentration equal to or greater than that specified in table 3.4.6 of Annex I of GB/NI CLP must be labelled with:
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) (ie the generic concentration limit for classification for sensitisation) the concentration limit for the special labelling requirement is 1/10 of the relevant specific concentration limit in accordance with Annex I of GB/NI CLP.
Potent Skin Sensitisers and In-Use Dilutions
Where a formulated PPP is considered to meet the criteria for classification for skin sensitisation in accordance with GB/NI CLP, its use must not present a risk to operators, workers, residents or bystanders. Whilst the risk of skin sensitisation can be mitigated with the use of gloves for the operator, this is not acceptable or realistic for workers, residents or bystanders, where the risk of skin sensitisation can be mitigated only by removing the hazard. These groups are normally exposed to the in-use dilution of the formulated PPP. In turn 'removing the hazard' means that the lowest in use dilution specified on the label (meaning the most concentrated in‑use dilution) must not meet the criteria for classification for skin sensitisation. For instance, for a product classified in category 1/1B for skin sensitisation, 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, a robust justification must be provided that demonstrates that the lowest in use dilution (most concentrated) does not present a risk to workers/residents/bystanders for skin sensitisation. This may be achieved by consideration of the final concentration of known sensitisers in the in-use dilution or potency information of the formulated product from available experimental data.