Source: https://www.bvl.bund.de/EN/04_PlantProtectionProducts/12_Fachmeldungen_EN/2011/Changes_authorisation_procedure.html?nn=2153768
Timestamp: 2018-05-27 00:58:25
Document Index: 538261059

Matched Legal Cases: ['§ 15', 'Art. 80', '§ 15', '§ 15', 'Art. 80', 'Art. 29', 'Art. 43', '§ 15', 'Art. 40', 'Art. 29', 'Art. 40', 'Art. 40', 'Art. 29', 'Art. 80', 'Art. 80', 'Art. 80', 'Art. 43', 'Art. 80', 'Art. 80', 'Art. 43', 'Art. 45', 'Art. 45', 'Art. 51', 'Art. 46', '§ 6', 'Art. 46', 'Art. 46', 'Art. 54', '§ 1', 'Art. 54', 'Art. 29', 'Art. 29', '§ 16', 'Art. 43', 'Art. 43', '§ 16', 'Art 43']

BVL - Technical information - Changes to the authorisation procedure for plant protection products
Changes to the authorisation procedure for plant protection products
The new EU Plant Protection Product Regulation will come into effect on 14 June 2011 (EC Regulation No 1107/2009). As a result there will be numerous changes to the authorisation procedure for plant protection products.
The Federal Office of Consumer Protection and Food Safety (BVL) provides some answers below to the most important questions from applicants and authorisation holders. The following information is updated regularly. All statements reflect the current situation.
EC Regulation No 1107/2009 will constitute law in force and will take immediate effect as from 14 June 2011. However, the Regulation contains numerous transitional provisions. For example, applications for authorisation which are still being processed on the cut-off date will continue to be processed according to old legislation.
As from 14 June 2011 the national legal bases will consist of the act on provisional implementation of provisions in the European Union which will take immediate effect concerning the authorisation or approval for placing plant protection products on the market (transitional law). To begin with, this transitional act is effective at the same time as the present Plant Protection Act. Both will be replaced later by the act on restructuring plant protection legislation (“new Plant Protection Act“).
How will submitting an application change?
As far as the application documents are concerned there will only be a few changes to the previous procedure:
The actual application form will be adapted soon by the BVL. For technical reasons the form for online applications cannot be amended by the cut-off date; the template which has been used up to now will continue to be used; an additional instructions leaflet will be added.
In future, the “checklist for completeness for zonal applications“ will be added to the application documents.
Applicants are recommended to discuss their application with the BVL before it is submitted, especially if Germany is to act as the zonal rapporteur Member State. Moreover, the "Form to notify intended zonal applications under Regulation (EC) No 1107/2009" should be filled in and submitted to the BVL and the respective competent authorities in the other Member States involved at the latest 6 months before the application is due to be submitted (see link below).
Can provisional authorisations according to § 15c PflSchG (German Plant Protection Act) still be granted after 13 June 2011?
EC Regulation No 1107/2009 does not make clear whether provisional authorisations are possible after the cut-off date. At the Standing Committee meeting on 10/11 March 2011 the European Commission stated: "The Commission furthermore notes that Regulation (EC) No 1107/2009 does not contain an explicit reference to this question and therefore leaves some uncertainty on this issue. … The Commission considers that it can be deducted from Article 80 (1) of the Regulation that, for that group of substances, provisions of Directive 91/414/EEC, with regard to provisional authorisations, remain applicable until the date of decision on the approval ….“
The BVL will also grant authorisations in the following cases after 13 June 2011 according to old legislation if the active substance concerned comes under Art. 80 (1) of EC Regulation No 1107/2009:
Applications according to § 15c (1) PflSchG
Applications according to § 15c (3) PflSchG
This also applies to applications which are received after 13 June 2011.
If the active substance is approved before the three-year period expires, the BVL reviews the provisional authorisation on the basis of old legislation (according to Art. 80 (5) b alternative 2 of EC Regulation No 1107/2009), i.e. in Germany without the need for an application. The provisional authorisation would then still exist after this review (without the need for an application) until the 3 years have expired. Following this, an application according to Art. 29 of EC Regulation No 1107/2009 should be submitted in good time if the plant protection product is also to be placed on the market and used after the 3 years have expired. Instead of applying old legislation and the review without the need for an application, the authorisation holder can decide that the provisions of the Regulation can be applied. In this case he would have to submit an application according to Art. 43 of EC Regulation No 1107/2009 at the latest three months after the inclusion of the active substance in Annex I of Directive 91/414/EEC or after the approval of the active substance.
What is the legal basis for the mutual recognition of authorisations?
After the cut-off date, the BVL will also decide on applications according to § 15b PflSchG which were submitted before 14 June 2011 on the basis of old legislation.
After 13 June 2011 only applications according to Art. 40 of EC Regulation No 1107/2009 can be submitted. Only authorisations which were granted according to Art. 29 of EC Regulation No 1107/2009 can be recognised mutually via Art. 40. Old authorisations which were granted according to Directive 91/414/EEC cannot be recognised mutually via Art. 40 of EC Regulation No 1107/2009.
If the authorisation was granted in another Member State according to Directive 91/414/EEC, the authorisation holder can submit an application for authorisation according to Art. 29 of EC Regulation No 1107/2009. Depending on the quality of the documents and the assessments from the reference authorisation, these could be taken into consideration accordingly in the authorisation procedure which could lead to a shorter procedure.
Do applications which are received by the BVL before 14 June 2011 have to be submitted in their entirety?
It is not possible to submit incomplete applications just to meet deadlines. Applications which do not meet the usual minimum standards are not applications in the sense of Art. 80 (5) of EC Regulation No 1107/2009 and will be rejected by the BVL because they are not admissible.
How long are authorisations which were granted according to old legislation valid?
If an authorisation was granted before 14 June 2011, the duration stated in the respective authorisation certificate applies. This is a result of the draft of the transitional act.
For authorisations which were applied for before 14 June 2011 but were not decided on until after 13 June 2011 old legislation applies according to Art. 80 (5) a of EC Regulation No 1107/2009. This means that the duration of authorisation is also determined according to old legislation, and is 10 years as a rule.
If an active substance contained in the plant protection product is approved or reviewed within the duration of authorisation, the authorisation must be renewed in line with the provisions of the Regulation. This ensues from Art. 80 (5) p. 2 of EC Regulation No 1107/2009. In this case the authorisation holder must submit an application for renewal of authorisation according to Art. 43 of EC Regulation No 1107/2009.
If the active substance comes under Art. 80 (1) of EC Regulation No 1107/2009, the authorisation is reviewed with regard to Art. 80 (5) b alternative 2 of EC Regulation No 1107/2009 on the basis of old legislation, i.e. without the need for an application. In this case the authorisation holder is also free to submit an application according to Art. 43 of EC Regulation No 1107/2009.
What is the legal basis for applications for amendments and extensions of uses for old authorisations?
Authorisations which were granted before 14 June 2011 and authorisations which were applied for before 14 June 2011 but will not be decided on until after 13 June 2011 can be amended or extended by submitting applications according to Art. 45 or 51 of EC Regulation No 1107/2009. It can be assumed that the procedures according to Art. 45 and Art. 51 of EC Regulation No 1107/2009 are zonal procedures.
In the case of an application for the extension of uses the applicant must submit a draft Registration Report (dRR) for the purpose of amendment. If the dRR only refers to the amendment / extension, it has to be formulated in a conclusive manner. This means that the authorisation holder may have to show data relevant to assessment from the original main authorisation as well. Only in this way is it possible for the other Member States to trace the changes and to later mutually recognise an amended authorisation such as this.
Which deadlines apply to old authorisations for using up and selling off stocks?
Art. 46 of EC Regulation No 1107/2009 applies from 14 June 2011. This is a discretionary norm which is directed at the Member States and which requires a further national enforcement act. The legislator must therefore make arrangements in the new Plant Protection Act.
The question is, what applies until the new Plant Protection Act enters into force? The provision in § 6a (3) No 1 PflSchG which also applies should not be open to an interpretation which is consistent with European law in the sense of Art. 46 of EC Regulation No 1107/2009 and should therefore not be applied. According to the competencies which are stipulated in the transitional act however, the BVL can decide on deadlines for using up and selling off stocks. Until the new Plant Protection Act enters into force, the BVL would therefore stipulate deadlines for using up and selling off stocks according to Art. 46 of EC Regulation No 1107/2009 of 6 or 18 months for products whose authorisation ends as from 14 June 2011.
What new requirements will there be for approvals for trial purposes as from 14 June 2011?
In comparison to the law in force up to now, according to Art. 54 of EC Regulation No 1107/2009 the application of plant protection products for trial purposes must also be approved if the product is released into the environment. According to § 1 (1) No 10 of the transitional act, the BVL is the competent authority in this respect. According to Art. 54 (2) of EC Regulation No 1107/2009, a dossier must be enclosed which contains all available data for assessing possible effects on animal or human health or the environment. The BVL will shortly be providing a new form for these approval applications.
What happens when Step 2 of the Post-Annex-I-Procedure is pending in another Member State whilst the German authorisation for this product takes several years?
The authorisation holder could decide to submit an application according to Art. 29 of EC Regulation No 1107/2009 after 13 June 2011 in Germany. If Germany is the evaluating Member State in the zonal procedure (zRMS) and the other Member States carry out Step 2 as co-Member States (cMS), this should not be a problem since the demands on the zonal procedure are higher than on the voluntary work sharing in Step 2.
If Germany were cMS and another Member State completed Step 2 in the voluntary zonal procedure, the following problems could arise:
The rapporteur (RMS) takes his time in Step 2 (e.g. longer than one and a half years) until the final registration report (RR).
A dRR is not submitted for commenting.
Up until now, the Member States in the central zone have declared themselves willing in this case to send the dRR on time for commenting to all cMS. Under this prerequisite the BVL is prepared to accept applications according to Art. 29 of EC Regulation No 1107/2009 in the context of a voluntary zonal procedure.
However, if the RMS should take its time up to the final RR and not keep to the deadlines according to EC Regulation No 1107/2009 for the procedure, this would also lead to a longer duration of the procedure with Germany as the cMS.
Can old authorisations be extended?
As long as the new Plant Protection Act has not entered into force, extensions are possible according to § 16 (2) PflSchG and Art. 43 (6) of EC Regulation No 1107/2009. However, the national norm would not be applied because European law has precedence. The BVL would therefore extend an old authorisation without the need for an application according to Art. 43 (6) of EC Regulation No 1107/2009 if an application for renewed authorisation (according to old or new legislation) was submitted on time and the decision on renewed authorisation is delayed for reasons which are not under the authorisation holder's control.
When the new Plant Protection Act enters into force, the present Plant Protection Act and therefore also § 16 (2) will be replaced. From this time onwards, extensions for authorisations which were granted according to Directive 91/414/EEC would also be handled according to Art 43 (6) of EC Regulation No 1107/2009.
Form to notify intended zonal applications under Regulation (EC) No 1107/2009 (rtf, 381 KB, File does not meet accessibility standards.)