Import tolerance setting in the EU

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1 Import tolerance setting in the EU Residues Workshop Brussels, 26 th -27 th January Euros Jones

2 Import tolerances Import tolerance Ø MRL set for imported products where: - the use of the active substance is not authorised in the EU, or - a different level is appropriate for the specific product and specific use;

3 Import tolerances What is the view of ECPA and the CP industry? Ø To set EU MRLs where possible and to ensure the availability of products and crop uses for European farmers Ø Only when an EU MRL is not needed or not possible, to set import tolerances to allow trade Ø Reduce the risk of trade distortion which also requires the EU to move back to a risk assessment process for plant protection products.

4 New challenges in setting import tolerance Two procedural issues of concern that could impact trade: 1.Import tolerances for substances not authorised in the EU 2.Procedure delaying the setting of import tolerances There are also other practical concerns these are not covered in this presentation

5 Import tolerances For cut-off ASs

6 Import tolerances for substances not authorised in the EU Numerous examples where active substances are not authorised in the EU but are important in third countries The application of cut-off criteria has raised questions about the future setting of import tolerances This is an issue that is still under discussion in DG SANTE

7 Import Tolerances (ITs) Question: If an AS is cut-off by the EU legislation, can Commission set an import tolerance for third country trade? Commission legal view?: Ø Both interpretations possible for substances captured by ED and other cut-off criteria Ø Both positions likely to be challenged! Legal advice opens the way for a political decision by the Commission Ø ECPA request: support trade friendly option!

8 Import tolerances for substances not authorised in the EU Key considerations: Import tolerance setting under Regulation 396/2005 should be based on a consumer risk assessment! Implementing a hazard based evaluation for import tolerances would raise questions Legality? Impact on trade?

9 Endocrine disruption criteria Regulation 1107/2009 required criteria by end-2013 Assessment still on-going Public consultation Ended on 16 January 2015 Impact assessment being carried out Assessment of impact on individual substances (2015) Agronomic & Socio-economic impact (2016) Criteria to be proposed in late 2016 External assessment on trade impact in 2013

10 Impact on Trade Globally, 65 billion of EU imports potentially affected by ED cut-off criteria 6.9 billion 6.9 billion 24.3 billion 8.4 billion 7.9 billion More information on methodology is available Category m (2012) Fruit and Nuts 13,795 Animal Feed 9,780 Ingredients Oilseeds and 9,574 Groundnuts Coffee, Tea 9,470 and Spices Vegetable Oil 8,222 Cereals 4,613 Cocoa 4,336 Vegetables 3,525 Sugar 2,046 Total 65,362 Helping Farmers Grow

11 Import tolerances for substances not authorised in the EU Suggested way forward The setting of import tolerances should be based on a robust risk assessment process System needs to be : Compatible with international commitments (SPS) Predictable to support trade Hazard based cut-off criteria should not impede the import tolerance process Avoid possible distortion requires a risk (not hazard) based system for product authorisation in EU

12 Import tolerances For new substances and uses

13 Setting new import tolerances Industry has traditionally applied for import tolerances in parallel to product/use applications in third countries Aim is to have EU import tolerance by the time the product is authorised (in EU and in third countries!) EFSA view is they do not want to evaluate until authorisations are in place in third countries This is very different to the EU procedure where MRL is needed before products are authorised!!

14 Commission letter on setting new import tolerances import tolerance requests should not be evaluated neither by the evaluating Member State, nor by EFSA until: evidence has been provided that the respective use is authorised in the exporting country and that the MRL proposed as an import tolerance is not higher than the one established in the country of origin.

15 POTENTIAL FOR MAJOR TRADE IMPACT! Impact on new import tolerances Ex.: Product authorised in third country in January 2015 Product used in March 2015 Crop exported to EU in May 2015 IT application in February 2015 MS evaluation in 4 months (June 2015) >> 1 year later EFSA evaluation in 4 months (October 2015) Standing Committee vote in 3 months (January 2016) Comitology in 3 months (April 2016) Publication of IT - May 2016

16 POTENTIAL FOR MAJOR TRADE IMPACT! Impact on new import tolerances Ex.: Product authorised in third country in January 2015 Product used in March 2015 Crop exported to EU in May 2015 IT application in February 2015 (Current timelines) MS evaluation in 11 4 months (June (January 2015) 2016) >> 1 year later EFSA evaluation in 64 months (July (October 2016) 2015) Standing Committee vote in 43 months (Nov (January 2016) 2016) Comitology in 3 months (Feb (April 2017) 2016) Publication of IT - March May

17 Impact on new import tolerances Working together Need to highlight potential impact on trade Potential impact on residue monitoring results as well!! Need to ensure a system that will allow timely setting of import tolerances

18 Conclusions

19 Import tolerances Conclusions Ø Industry s aim is to set EU MRLs where possible and to ensure the availability of products and crop uses for European farmers Ø Where separate import tolerances are needed, an efficient risk based process is needed to minimise trade disruption and residue exceedences. Ø Distortion of competition a concern return to risk based system would be best!

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