Since 14 June 2011, Regulation (EC) 1107/2009 applies. At the same time, the Plant Protection Products Act 2011 came into force. Thereby the Plant Protection Products Law 1997, the Federal Republic of Germany Equality Regulation as well as the Kingdom of the Netherlands Equality Regulation have been overridden.
In addition, the Plant Protection Products Ordinance 2011 was published in the Federal Law Gazette II Nr. 233/2011 on 25 July 2011. The Regulation on the Plant Protection Products Act 2011 came into force in essential parts on 14 June 2011. However, it i.a. also contains important transitional arrangements regarding application procedures and authorisation of plant protection products.
Below are some questions from real life that have forwarded to AGES and/or BAES, respectively, by the Austrian Chamber of Agriculture:
Re-entry periods for greenhouses: Does this also apply in Austria and if so, how?
Re-entry periods will not be assigned in general but individually and are based on a risk assessment carried out within the authorisation of a plant protection product. The respective safety information and requirements can be found, where appropriate, on trade packages or can also be looked up in the Plant Protection Products Registry on the Internet.
Below is an example of how such a safety notice might be phrased:
The re-entry of the treated areas/crops is only possible with personal protective equipment on the day of application, which is given for the application of the agent. Follow-up work on/in treated areas/crops may generally only be performed 24 hours after application of the agent. During 48 hours, the protective suit against plant protection products and universal protective gloves (plant protection) must be worn.
Will there be uniform Austrian sales periods or will they be state-specific?
The period for placing on the market of plant protection products is regulated by Regulation (EC) No 1107/2009 and thus provides a harmonised framework for the award throughout the EU. The grace period is limited to 6 months for sale and distribution and an additional maximum of 1 year for the use of existing stocks. An application for amendment or renewal of the authorisation that has been received by BAES before 14 June 2011 is to be decided on the basis of the existing legal situation until then. In the latter case, a sales period of a maximum of 12 months might apply.
Article 46 of Regulation (EC) No 1107/2009:
Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.
Where the reasons for withdrawal, amendment or non-renewal of the authorisation are not related to the protection of human and animal health or the environment, the grace period shall be limited and shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned.
Zonal ratings are created for an entire zone. Should a third party (producer organisation, corporation, etc.) want to obtain an authorisation in the same zone in another country, is the data/authorisation holder then obliged to hand over this information? What legal significance would this have for the new holder?
Formally, an applicant must possess a full dossier. This can be achieved by meeting the following conditions/circumstances:
- own dossier
- letter of access from the data owner, to be provided country-specific, addressed to the relevant competent authority
- reference to non-protected data
- agreement on transfer of test and study reports (avoid duplicative testing, Article 61 of Regulation (EC) No 1107/2009)
At present there is no general obligation to provide data exploitation for third parties.
What will be the provision for plant protection products register numbers in the future?
No significant changes are planned by BAES in the short term.
How long is the continued use of German and Dutch approved products that are registered in Austria under Section 3 (4) of the Austrian Plant Protection Products Act (PMG) 1997 for placing on the market, permitted?
Plant protection products registered as of 13 June 2011 in accordance with Section 3 (4) of the Austrian Plant Protection Products Act (PMG) 1997, may be placed on the market until 31 December 2013 for use in Austria, provided that certain conditions are met.
Section 15 (8) of the Austrian Plant Protection Products Regulation 2011
Plant protection products in accordance with Section 3 (4) of the Austrian Plant Protection Products Act 1997 may be placed on the market when labelled accordingly until 31 December 2013, provided that the registration in the Member State of origin is still valid and conformity is given with the legislation of the European Union.
Pursuant to the explanatory notes on the present regulation, the use of plant protection products is permitted until 31 December 2014, unless there are other reasons for exclusion as stated above.
May such products still be bought by the Austrian farmer after 14 June 2011 in neighbouring countries such as e.g. Germany to then be applied in Austria or may – according to the new legislation – a farmer purchase a plant protection product authorised in Austria, which is also authorised for use in Germany (and therefore in the middle zone) and has perhaps even been evaluated by Germany, in Germany and use it in Austria?
GIn accordance with Article 52 of EU Regulation 1107/2009 the direct purchase of a plant protection product from another Member State requires an application by the user for parallel trade. Only once this parallel trade permit has been granted by the Austrian Federal Office for Food Safety (BAES), can the farmer purchase the product directly from abroad.
What happens with products reported in accordance with Section 3 (4) of the Austrian Plant Protection Products Act (PMG) 1997 whose authorisation is renewed in Germany and the Netherlands during the transitional period?
For original authorisations, the period is extended until 31 December 2013 (exceptions: German parallel imports on the basis of certificates of marketability; specific wording changes in Germany which require a new authorisation number).
Does the new Plant Protection Products Law still allow for the possibility of 'ex-lege' authorisations? For example: can an indication for eggplant in protected cultivation in Spain also be used for 2 hectares of arable land in Austria?
No. Regulation (EC) No. 1107/2009 shall apply and does not provide such a possibility.
Do beneficial organisms count as plant protection products across Europe?
No. Beneficial organisms (macro-organisms) are not a provision laid down in Regulation (EC) No. 1107/2009. Member States may therefore establish their own legal framework in this matter. In Austria, the use of beneficial organisms is considered to be a plant protection measure, i.e. an authorisation is necessary for distribution and use.
What happens to plant strengtheners or what status will they have in the future, respectively?
In Austria, plant strengtheners are regulated in the Austrian Fertiliser Act. The listing procedure remains upright in Germany until further notice, except for products falling under Regulation (EC) No. 1107/2009 (please refer to the website of the German Federal Office of Consumer Protection and Food Safety (BVL) regarding plant strengtheners).
Are the import and use of identical plant protection products still possible within a zone as well as across zones? How can the 'identity' of plant protection products be checked? Within a zone and between the three zones?
Parallel trade of plant protection products is not subject to any zone control.
Article 52 of Regulation (EC) No. 1107/2009 will apply mutatis mutandis.
Will there be special authorisations in the new Austrian Plant Protection Products Law, such as they currently exist in Germany's Section 18a and 18b?
The Austrian Federal Office for Food Safety (BAES) is entrusted with enforcement and bound to the existing legal situation. The former possibility of extending an indication in the public interest is now governed by Article 51 of Regulation (EC) No. 1107/2009.
When will professional users be classified as such and thus have to keep records?
The record-keeping requirement relates to professional users in general, regardless of which products are used.
Article 67 of Regulation (EC) No. 1107/2009
(1) Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years. Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used.
Which provisions are applicable to final-sale horticulterers who sell plant protection products for home and hobby garden use to consumers? Are a separate training and/or certain qualifications required for this?
With the Plant Protection Products Regulation 2011, detailed provisions relating to tax, purchase and storage, training and certification were i.a. set. A quantity regulation from which the possession of a certificate becomes imperative was introduced for small distributors in particular. The detailed provisions can be found in Sections 1 to 3 of the Plant Protection Products Regulation 2011. A transition period is granted until 26 November 2015 for the full implementation of these provisions.
- The statutory regulations are only cited in part. With regard to the complete and legally binding versions of the listed statutory provisions please refer to the Federal Law Gazette or the Official Journal of the European Union.
- With regard to the complete and legally binding version of the applicable national legislation please refer to the bulletins in the respective Federal State Law Gazettes.
- With respect to a legally binding interpretation of the applicable national legislation please refer to the competent legal services of the respective Federal States.
- The replies represent the views of AGES and are not legally binding. Any liability of the author/AGES is excluded. E&OE.