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 for chemical active substances are listed in Commission Communication 2023/C 344/02 (active substances) or 2023/C 344/01 (products). For microorganisms, the Commission Communications 2023/C 202/03 (active substance) or 2023/C 202/02 (products) apply 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.

• Specification of active substances in the authorisation procedure for plant protection products (in German)

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.

• https://food.ec.europa.eu/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_sanco-2009-6075_rev-03.pdf

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. For this purpose, an application for changing the production of the technical active substance must be submitted. The application is preferably made via the applicant portal. Alternatively, the signed application form can be sent to the BVL as hardcopy, together with the required documents on CD-ROM (preferably, in a searchable file format).

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.

• Application for a change in the production of the technical active substance (rtf)
• Document SANCO/10597/2003: Assessment of the Equivalence of Technical Materials (pdf)

Assessment of equivalence apart from the authorisation procedure of plant protection products

Until further notice, the BVL will only accept applications for equivalence assessments if
o The new active substance source is intended for a plant protection product in Germany (existing authorization or Germany is zRMS in the ongoing authorisation procedure).
or
o Germany was the rapporteur Member State (RMS) of the existing approval of the active substance.
If this is not the case, applicants are advised to contact either the RMS of the active substance concerned or the zRMS in the zonal authorisation procedure.

The provisions of Article 38 of Regulation (EC) No. 1107/2009 say that the BVL can also be asked for equivalence assessment of a technical active substance if Germany is the rapporteur Member State for the active substance.
In that case, the BVL will make the assessment according to the criteria of Guidance Document SANCO/10597/2003 while using an accepted reference specification, prepare an equivalence report, and communicate the report to the Member States for commenting.

The application is preferably made via the applicant portal. Alternatively, the signed application form can be sent to the BVL as hardcopy, together with the required documents on CD-ROM (preferably, in a searchable file format). The links to the application form and to the SANCO guidance document are provided in the paragraph above.

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.

• Marking of technical active substances in plant protection products

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:

• Evaluation of microorganisms at taxonomic/strain level

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. Annex III was filled for the first time with Regulation (EU) 2021/383. Other toxicologically or ecotoxicologically relevant co-formulants subject to national restrictions are included in the "List of unwanted co-formulant substances in plant protection products".

• List of unwanted co-formulant substances
• Function of co-formulants
• Co-formulants in authorised plant protection products

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.
• Processing times depend on the extent of the planned change.
• 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.

• Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products

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.

• Applying for and amending packaging for plant protection products

The BVL then issues an amendment notice.