Standard data requirements for the inclusion of an adjuvant on the Official List of Adjuvants
a) A technical specification for the Effective Adjuvant Component (EAC) detailing the minimum content (% w/w or g/kg) of pure EAC (excluding inactive isomers) and maximum levels (% w/w or g/kg) of impurities in the manufacturing material used for production of the formulated product. The minimum purity of the EAC and sum of maximum amounts of impurities must be ≥ 100%.
It must be stated whether impurities of toxicological, ecotoxicological or environmental significance are present. If present, the maximum level of these impurities will need to be defined. (An example of a toxicologically significant impurity that may be present in adjuvants is free ethylene oxide).
The technical specification must use chemical names as given in Annex I of Directive 67/548 (GB/NI) or in accordance with IUPAC and/or CAS nomenclature. The information submitted must be enough to chemically characterise that component. For example, for polyethoxylated components the information should include the degree of ethoxylation and the number of moles of ethylene oxide. In addition, where a component is itself a mixture, full details of the mixture (including ratios of sub-components, if appropriate) must be submitted.
Other specific information on the EAC must also be presented in a separate form and submitted together with the application form.
Where you are submitting an application for a new EAC you will also need to submit a document providing information on the nomenclature of the EAC.
Information required includes:
- CAS/EC (ELINCS/EINECS) number(s) must be given where available
- a description of the chemical composition must be included to supplement the chemical name. For example, ‘PO-EO block co-polymers with approximate chain lengths and molar masses’
- if trade names are included in the technical specification, these must be in addition to, and not instead of, the full chemical names; alternative trade names may only be listed if they are of the same chemical composition
A technical specification is required for each source of an EAC. A ‘source’ refers to a technical material manufactured by a specific process in a particular location and is described by an individual technical specification and its supporting data package.
b) A method of manufacture of the EAC to include the minimum purity of the effective component produced as a result of the manufacturing process.
c) Full formulation details are required as detailed below:
- the nominal amount of EAC in the formulation must be specified in units of % w/w, g/kg, or g/l, as appropriate
- for co-formulants the following information must be specified:
- chemical name as given in Directive 67/548/ (GB/NI), Annex I or in accordance with IUPAC and/or CAS nomenclature. The information submitted for each co-formulant must be enough to chemically characterise that component. For example, for polyethoxylated components the information should include the degree of ethoxylation and the number of moles of ethylene oxide. In addition, where a component is itself a mixture, full details of the mixture (including ratios of sub-components, if appropriate) must be submitted
- function of co-formulant, for example emulsifier
- the nominal amount of each co-formulant present in the product must be given in units of %w/w, g/kg, or g/l as appropriate
- a description of the chemical composition must be included to supplement the chemical name. For example, xanthan gum, heteropolysaccharide molar mass 2 to 15 x 106 g/mol
- trade names where possible must be stated, including alternatives if required. Where alternative trade names are listed, the components must be identical in chemical composition. Where the alternatives are not chemically identical then a reasoned scientific case must be submitted showing why the change will not adversely affect the physical or chemical properties of the formulation
- CAS/EC (ELINCS/EINECS) number(s) must be given where available
- colour index number for dyes
- a method of analysis for determining the EAC in the adjuvant formulation
d) Such basic physico-chemical properties of the EAC as water solubility, octanol-water partition co-efficient, melting point and boiling point. Where certain properties are not relevant to a proposed adjuvant product, HSE encourages applicants to generate some basic physical and chemical properties data that are appropriate. The following tests could be considered appropriate: hydrophile-lipophile balance (HLB), pH, viscosity, surface tension, appearance, odour and density. (It would be preferable if these studies were conducted to GLP, but this is not a requirement).
It should be noted that whilst some physico-chemical properties are available on Safety Data Sheets, all the relevant properties may not be reported, especially the octanol-water partition coefficient. (It is recognised that for adjuvants with surface acting properties (for example surfactants) meaningful measurements of octanol-water partition coefficients are not possible and therefore not relevant).
e) For uses on crops destined for human or animal consumption, UK residues data (or data from a country with comparable climatic and agricultural conditions) must be submitted, showing the effects of the adjuvant on pesticide residue levels. A relevant range of pesticide products, crops and application conditions should be examined. The data should be presented as a direct comparison with data generated from use of the pesticide on its own and enough samples should be analysed to identify any significant effect. Further guidance on the submission of residues data is given on our website. This includes guidance on certain claims for use with pesticides that do not require the submission of residues data .
g) Any other data deemed necessary based on the above.
You should perform any studies relating to the safety areas of the risk assessment to Good Laboratory Practice (GLP) in accordance with Directive 87/18/ (GB/NI) as amended by Commission Directive 1999/11/ (GB/NI). The directive requires competent authorities to ensure that laboratories carrying out tests on chemical products comply with the principles of GLP so that results are comparable and of high quality. This supports the principle of mutual acceptance of data for the evaluation of chemical products so that tests, particularly those involving animals, do not have to be repeated because of differences in laboratory practice from one MS to another.
If you have access to a previously submitted full data package on an EAC used to support a previously considered list entry, it is likely that you will not need to address all of the above data requirements unless the technical specification for the EAC, the formulation recipe or the recommended uses differ to those covered by a previous list entry. In such cases, certain new data may be required to support the list entry.