How adjuvants are regulated in the UK
Adjuvants are not plant protection products (PPPs); but, as they influence the way PPPs behave and the effects they have, they are subject to regulatory control.
Schedule 2 to the Plant Protection Products Regulations 2011 (SI 2011/2131) sets out the arrangements for authorising the use of adjuvants in the UK. This regulation carries forward long-standing national rules, as permitted by Art. 81(3) of the Regulation (EC) 1107.
Regulation (EC) 1107 defines 'adjuvants' as being:
'substances or preparations which consist of co-formulants or preparations containing one or more co-formulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product and which enhance its effectiveness or other pesticidal properties, referred to as 'adjuvants'.
HSE interprets the control over the use of the adjuvant with the PPP as being at the point when the adjuvant is in physical contact with the PPP in the tank. The list entry includes the specific conditions of use relating to controls over use. Any change to these conditions requires an application to amend the list entry.
The regulations enable Ministers to:
1. Set data requirements which must be met for an adjuvant to appear on the Official List of Adjuvants. These data requirements (adjuvant data requirements and residues data requirements) form the basis of the application evaluated by HSE to determine the safe conditions of use of the adjuvant with an authorised plant protection product. Inclusion on the Official List of Adjuvants cannot be given subject to confirmatory data requirements.
2. Determine the conditions to which the use of the adjuvant with a PPP are subject. These conditions of use are published on the list entry for each adjuvant product. These may be amended for safety reasons or at the request of the applicant.
3. Set further requirements in the light of available information relating to the use of the adjuvant with authorised PPPs. This may result from a review of an individual or group of adjuvants. If an adjuvant fails to pass a review, the product may be removed from the official list. Inclusion on the Official List of Adjuvants cannot be given subject to confirmatory data requirements.
4. Remove an adjuvant from the official list for a variety of reasons:
- if the applicant fails to comply with any data requirements (as part of an application for official listing, or review)
- if any relevant product literature is not in accordance with the published conditions of use of the adjuvant, (relevant literature includes the product labelling, any accompanying leaflet, or any other literature describing the product produced by the applicant)
- for safety reasons
- at the request of the applicant company
Although there are no direct legal controls over the marketing and advertisement of adjuvants, an adjuvant may be removed from the list if the label or any other relevant literature promotes the use of an adjuvant with a PPP in a way that would either contravene the conditions of use of the adjuvant as detailed in the list entry, or the PPP authorisation. HSE provides advice on the adjuvant label text in their letter accompanying the list entry for guidance.
Other relevant legislation
The aspects that are not controlled under the regulations (for example storage, operator protection prior to use, environmental and toxicological classification of adjuvants) are controlled by other legislation:
- the Health and Safety at Work Act, 1974
- the Control of Substances Hazardous to Health Regulations (COSHH) 2002 (as amended in 2004
- Regulation (EC)1272/2008 on classification, labelling and packaging of substances and mixtures. It is known by its abbreviated form: 'the CLP Regulation' or 'CLP'.Adjuvant products come under the definition of 'general preparations' and must be classified and labelled in accordance with CLP. You should provide details of proposed classification and associated labelling when you submit your application
When an adjuvant is supplied and marketed together with a PPP for mixing before use, known as a 'twin-pack', it is considered to be part of the authorised PPP.
Whether or not that adjuvant is on the official list, the plant protection product/adjuvant combination must be considered by HSE for safety and efficacy as part of an application for an authorisation of the PPP.