Regulatory Update: 03/2017
Issued: 25th January 2017
In vivo vertebrate tests should not be conducted for the purposes of fulfilling the requirements of Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market) where accepted alternatives are available and could reasonably have been used.
This update reminds applicants and testing facilities of their duties under Regulation (EC) No. 1107/2009 (‘the Regulation’) to avoid vertebrate testing and to use alternative methods, and also confirms that HSE will not accept in vivo studies where an accepted alternative is available.
This is a reminder of existing requirements so applies with immediate effect.
Regulation (EC) No. 1107/2009 aims to minimise vertebrate testing. When new, alternative OECD Test Guidelines become available that can fully or partially replace in vivo tests, any new studies submitted for the purposes of plant protection product regulation should be conducted using these alternatives. This requirement is in addition to considerations under animal welfare legislation (Directive 2010/63/EU - see Footnote).
The Regulation applied from 14 June 2011 and sets out a number of requirements aimed at avoiding unnecessary testing on vertebrate animals, including the avoidance of duplicate testing, and for the sharing of tests and studies involving vertebrate animals. In addition, the Regulation states in Article 62 (1) that:
‘Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available’.
Currently validated in vitro alternatives are available that can replace in vivo skin and eye irritation studies. For mixtures the calculation method can be used to replace in vivo studies for acute toxicity, skin and eye irritation and skin sensitisation when a reliable classification can be determined by this method.
In the UK, the Plant Protection Products Regulation 2011 (Statutory Instrument 2011 No. 2131) is the enforcing regulation for Regulation (EC) No 1107/2009 and provides under regulation 15(1) that:
(1) A person must not undertake tests on vertebrate animals in contravention of the first sentence of Article 62(1), or cause or permit another person to do so.
And under regulation 23 that:
A person who contravenes or fails to comply with –
(a) Any paragraph of regulations 9 to 13, 15 to 19, or 22;…… is guilty of an offence
The fact that a test may also be carried out for the purposes of an application or authorisation in another Non-EU regulatory body/authority which may have less stringent rules regarding testing on vertebrate animals does not invalidate the provisions of Article 62.
HSE will contact applicants where there is a concern that a breach of Article 62 (1) of the Regulation has occurred.
HSE will contact applicants where there is a concern that a breach of Article 62 (1) of the Regulation has occurred. This applies to vertebrate studies commissioned after 14 June 2011.
If any in vivo studies are submitted to HSE as part of an application for authorisation of a pesticide product or active substance, and the date of the study indicates it was commissioned after 14 June 2011 AND an acceptable alternative method (e.g. an adopted OECD Test Guideline for an in vitro alternative, or the calculation method) could reasonably have been used, then the application will be rejected. HSE will also consider whether to conduct an investigation in relation to the potential breach of article 62(1) of the Regulation.
The applicant may resubmit the application using either the calculation method or acceptable in vitro studies.
Any in vivo studies already submitted to HSE as part of an application for authorisation of a pesticide product or active substance will not be evaluated if an accepted alternative method could reasonably have been used, and the date of the study indicates it was commissioned after 14 June 2011. The applicant will be asked to provide an acceptable alternative method which may include an in vitro study or classification by calculation. As for new applications, HSE will also consider whether to conduct an investigation in relation to a potential breach of Article 62(1) of the Regulation.
Authorised products (or approved active substances) where in vivo studies were submitted to support that authorisation/approval when an appropriate alternative method was available at the time the study was commissioned will not have those authorisations or approvals revoked or re-evaluated. However, HSE will contact these authorisation holders to remind them of their obligations.
Pesticides: See the pesticide Applicant Guide on the HSE pesticides website for further information on vertebrate studies submitted under Regulation (EC) No. 1107/2009 for plant protection products:
Link to the Pesticide Applicant Guide.
Biocides: Please note that this Regulatory Update applies only to pesticides. When considering conducting vertebrate studies to support an application under Regulation (EU) No. 528/2012, please consult the HSE biocides website
Link to Biocides website.
Directive 2010/63/EU on the protection of animals for scientific purposes which updates and replaces Directive 86/609/EEC.