Navigation and service

Product chemistry - advice for applicants

Data requirements in the area of product chemistry are based on Regulation (EU) No 283/2013 (for active substances) and Regulation (EU) No 284/2013 (for products). The relevant test methods and guidance documents are listed in Commission Communication 2013/C 95/01 (active substances) or 2013/C 95/02 (products). The BVL has compiled detailed information on certain issues and questions.

Specification of technical active substances

The establishment of a specification ensures a constant level of quality with regard to the technical active substance. In the authorisation procedure the identity of the active substance forms the basis for subsequent evaluations. The following document illustrates the assessment of the specification, both for applications for new active substances and for changes in the production of existing technical material.

Harmonisation of the reference specification after the peer review

The approval of an active substance according to Regulation (EC) No 1107/2009 refers to technical material, the composition of which is defined by a reference specification. In certain cases the scientific assessment at EU level (peer review) is concluded without harmonising the reference specification among the Member States. The following guidance document describes the procedure for harmonising the reference specification. It should be noted that this procedure is not for amending Implementing Regulation (EU) No 540/2011. An applicant intending to amend the terms set down in this regulation should contact the European Commission directly.

Assessment of equivalence for applications for plant protection product authorisation

If the technical active substance contained in a plant protection product, for which an application for authorisation has been submitted according to Article 29 of Regulation (EC) No 1107/2009, has a different source to the active substance which was assessed in the EU evaluation programme for active substances (reference source) or if the respective production process was changed, the equivalence of the active substance from the new source is assessed and compared to the reference specification. The assessment of equivalence is then carried out according to Article 38 of Regulation (EC) No 1107/2009 as part of the authorisation procedure for the product applied for.

Changes which are made afterwards to the production of the technical active substance must be applied for at the BVL according to Article 45 of EC Regulation No 1107/2009. This applies to authorisations according to Regulation (EC) No 1107/2009 and for authorisations which were applied for on the basis of the law in force up to 14 June 2011. The form below is to be used for this purpose (Application for changing the production of the technical active substance). The application can generally only be submitted electronically. The application form and the required documentation can be submitted via the BVL applicant portal as supplementary documentation on the authorised product. If access to the applicant portal is not authorised for an authorised product (no pseudonym number exists), the signed application form can be sent to the BVL as hardcopy, together with the further documentation on CD-ROM.

Regardless of whether the assessment of equivalence is carried out during the authorisation procedure or after authorising the product, there are three different cases for complying with the stipulations of Article 38 of Regulation (EC) No 1107/2009:

  1. If no equivalence report is available for the new active substance source, this is compiled by the BVL and distributed to the Member States for commenting.
  2. If an equivalence report is available for the new active substance source but the conclusion is not harmonised with regard to the stipulations of Article 38, this report is still accepted by the BVL. A prerequisite is that the assessment is carried out according to the criteria of Guideline SANCO/10597/2003 using an accepted reference specification. Otherwise, the BVL compiles a revised equivalence report and distribute this to the Member States for commenting.
  3. If an equivalence report is available for the new active substance source and its conclusion is harmonised with regard to the stipulations of Article 38, there is no further assessment.

The deadlines for the procedure for the assessment of equivalence can be taken from the stipulations of Article 38 of Regulation (EC) No 1107/2009 and from the current version of Guidance Document SANCO/10597/2003. Please note that in cases 2 and 3 all the documentation submitted for the assessment of equivalence must also be submitted to the BVL.

Assessment of equivalence in the re-registration after an active substance has been approved

If Germany is the Rapporteur Member State for an active substance which was approved according to Regulation (EC) No 1107/2009 the BVL will assess the equivalence of the technical active substance for other Member States according to Guidance Document SANCO/10796/2003 (re-registration of plant protection products). To this end all authorisation holders must submit the corresponding documentation to the BVL without being asked to do so, regardless of which Member State they have authorisations in, before the implementing regulation concerned enters into force. After this the BVL will only assess equivalence in the context of applications for national authorisations (see paragraph above). The assessment of equivalence will be completed 6 months after the respective implementing regulation has entered into force. No fees are charged.

Marking of technical active substances and formulations

Certain marker substances can be added to technical active substances or formulations to authenticate legal products and to identify counterfeit products. Such marker substances must be notified to the BVL or be approved if applicable. Details on the marking procedure for technical active substances contained in plant protection products are described on the following page. The procedure for using marker substances in formulations follows.

Microorganisms

If microorganisms are used in plant protection products as active substances, evaluation should refer to the strain level of the microorganism. Information is provided on the following page:

Co-formulants

Annex III of Regulation (EC) No 1107/2009 contains a list of the co-formulants whose use is not permitted in plant protection products according to Article 27. Up to now this annex has no entries. However, for a transitional period the Member States can apply national provisions for co-formulants.

A series of toxicologically or ecotoxicologically relevant co-formulants have been replaced in plant protection products over the past few years. Plant protection products which contain a co-formulant mentioned in the "List of unwanted co-formulant substances" have no prospect of being authorised.

Changed formulations

An authorisation issued by the BVL is only valid for the formulation applied for. A change in the formulation of an authorised plant protection product requires either a notification to the BVL, a request for change or a new application for authorisation, depending on the extent of the change to the formulation.

The BVL proceeds according to Guidance Document SANCO/12638/2011 (rev. 2 of 20 November 2012) under Regulation (EC) No 1107/2009 when processing changed formulations. It does not contain instructions for the scientific assessment but rather the procedure which is to be followed:

  • Notifications are considered non-significant changes. In such cases zonal assessment is not necessary as a rule.
  • Changes are considered a change of authorisation and are processed according to Article 45 of Regulation (EC) No 1107/2009.
  • The results of the assessment are summarised in an addendum to the registration report. As a rule, this is distributed amongst the Member States for commenting.
  • The deadlines for processing depend on the extent of the planned change; however, the time frame according to Chapter 6 of Guidance Document SANCO/2010/13170 (rev. 7) applies. It is 6 months long for the competent authority concerned.
  • If the change to authorisation is planned in several Member States the applicant can suggest a certain Member State to carry out the assessment. As a rule this should be the zonal Rapporteur Member State (zRMS) of the formulation as currently authorised.

A cover letter should indicate clearly whether it is a notification or a change to authorisation.

Plant protection product packaging

All intended packaging must be stated in the application for authorisation. For applications for authorisation which are processed according to Regulation (EC) No 1107/2009 the allowed packaging is stipulated by the BVL in the authorisation certificate. If other packaging is intended later this must be applied for to the BVL; a corresponding notification of amendment will then be issued.

Two clicks for more safety: The element will be activated only after operating the slide control. Data protection information: By activating this external link you will leave the BVL website. We have no influence on the contents of the following website, in particular not on the protection of your personal data. For more information please see our data protection declaration, which you can find here.


© 2018 Federal Office of Consumer Protection and Food Safety