If the applicant has already performed vertebrate studies with the PPP, Czech Republic will accept these studies only if they comply with commonly approved methods and guidelines.

Regulation (EC) No 1272/2008 and Regulation (EC) No 1107/2009 do not stipulate information that studies that were already conducted should not be accepted.

Furthermore, according to the Regulation (EU) No 284/2013 (valid from 1.1.2014 and for submitted applications from 31.12.2015) testing on vertebrate animals is carried out only where there are no alternative methods (in vitro, in silico, etc.).

If the applicant submits the results of a study on vertebrate animals in the PPP assessment report, Czech Republic (NIPH) will request justification (with regard to Article 8 (1) (d) and Article 62 (1) of Regulation (EC) No 1107/2009), why a vertebrate study was performed and why the alternative methods were not used for classification and hazard identification.

For the assessment of the hazards of the PPP, the relevant calculation procedures should be used for the classification of the mixtures according to the Regulation (EC) No 1272/2008, as amended.

 According to the Regulation (EU) No 284/2013:

• Acute oral and dermal toxicity test: A test for acute oral and dermal toxicity shall be carried out, unless the applicant can justify an alternative approach under Regulation (EC) No 1272/2008
• Acute inhalation toxicity test: A study shall not be required if the applicant can justify an alternative approach under Regulation (EC) No 1272/2008, where applicable. For this purpose, acute inhalation toxicity of all components shall be provided or reliably predicted with a validated method.
• Skin irritation: The skin irritancy of the plant protection product shall be reported based on the tiered approach, unless the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, skin irritation properties of all components shall be provided or reliably predicted with a validated method.
• Eye irritation: Eye irritation tests shall be provided, unless it is likely that severe effects on the eyes may be produced or the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, eye irritation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the irritant potential of the total mixture.
• Skin sensitisation: The skin sensitisation test shall be carried out unless the active substances or co-formulants are known to have sensitising properties or the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, skin sensitisation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the sensitising potential of the total mixture. The local lymph node assay (LLNA) shall be used, including where appropriate the reduced variant of the assay. In case the LLNA cannot be conducted, a justification shall be provided and the Guinea Pig Maximisation Test shall be performed. Where a guinea pig assay (Maximisation or Buehler), meeting OECD guidelines and providing a clear result, is available, further testing shall not be carried out for animal welfare reasons. Czech Republic accepts in vitro skin sensitization tests (e.g. B.59 / OECD 442C and B.60 / OECD 442D method).

 An overview of the regulations cited above:

Regulation (EC) No. 1272/2008, on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
Regulation (EC) No. 1107/2009, concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Regulation (EU) No. 284/2013, setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
Regulation (EC) No. 440/2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)