• General
• Confidentiality
• Listing markers
• Procedure of notification
• Approval procedure

General

Substances which are added to technical active substances to authenticate legal products and identify fake products are called markers. Regulatory details on marking of technical active substances in plant protection products are described in the following. The marking of formulations is not part of this procedure.

Although the use of markers and the data requirements to be fulfilled are not stated explicitly in Regulation (EU) No 283/2013, markers are regarded formally as additives to technical active substances. It can therefore be concluded from Regulation (EU) No. 283/2013 that the competent authority must be notified about the composition of the technical active substance in conjunction with the addition of a marker and that such a change must be approved by the authority. The BVL requires the following data and documentation until the Member States have agreed on a uniform interpretation of the law and a corresponding procedure at EU-level.

In principle, the applicants must give evidence that the marking substances added are not of toxicological or ecotoxicological concern. Furthermore, only minimum amounts of marking substances should be added to the technical active substance to achieve the marking. The applicant himself is responsible for assuring the stability of the marker in the technical active substance and in the formulation. The BVL does not carry out an evaluation to this end.

Corresponding with the publication on changes in the production of technical active substances in plant protection products (Federal Gazette No. 203, (2006), p. 6795 and on the BVL website), notification of a change must be given or an approval applied for, depending on the issue. Although the publication stated above only applies to impurities, it can also be used to a large extent for additives to technical active substances. The particularities for markers are described in the following.

Each applicant can compile a specific positive list of potential markers beforehand independently of a concrete application for the authorisation of a marker. Such positive lists enable the respective applicant to select a marker afterwards from his own list and to have the marking of a certain active substance registered in a procedure of notification. If a single new marker which has not yet been included in the positive list of the applicant is to be used for marking an active substance, this can be applied for within the approval procedure.

Confidentiality

The use of markers can only be successful if their chemical identity is known to as few people as possible. In order to guarantee this special confidentiality, the confidential part of the documentation can be sent by separate post to the BVL, addressed to the head of the department for plant protection products (labelled 'confidential'). In addition, a coding is allocated. This means that each potential marker receives a code from the applicant which is used in further communication between the BVL and the applicant. Special confidentiality is also observed and an internal code for the marker is used if this documentation is passed on from the BVL to the Federal Institute for Risk Assessment (BfR) and the Federal Environmental Agency (UBA) and in any further communication between the authorities. The identity of the marker is passed on by the BVL without the applicant's code.

If an applicant prefers not to know the identity of the marker, he can commission a third person to select the marker. He must then inform the BVL. The BVL requests the confidential part of the documentation from this third person; this should be sent directly to the head of the department for plant protection products at the BVL. In this case, only the code name is used for correspondence with the applicant. If requested, different codes can be agreed on for communication between the BVL and the applicant and between the BVL and the commissioned third party.

Listing markers

Before filing an application, it is recommended that a list with potential markers be submitted without allocating these to an active substance. This will assure more confidentiality, since at this moment in time no decision has been made as to which marker will actually be used. If, on the basis of the evaluation of the submitted documentation, it can be confirmed that these substances do not give rise to toxicological and ecotoxicological concern, a marker can be selected from the respective applicant's positive list for a procedure of notification using the code name without having to state the chemical identity. The following confidential documents must be submitted for listing markers:

• code name for marker
• chemical identity of marker (IUPAC name, CAS no., molecular formula and structural formula)
• safety data sheet for the marker
• evidence from evaluation or scientifically founded justifications on the fact that the marker causes no toxicological or ecotoxicological concern

However, the evaluation of lists with potential markers requires additional work, in particular if these are often updated. Therefore, the lists should only be updated twice a year, on 31 May and 30 November. The proposals submitted to the BVL by these dates for updating the lists are then passed on to the BfR and the UBA for assessment. The applicants are informed promptly of the assessment results.

Procedure of notification

Only a procedure of notification is required if the marker is listed in the applicant's own positive list of markers accepted by the BfR and UBA or is already an authorised food additive in accordance with the German Food Additives Authorisation Ordinance (ZZulV of 29.01.1998, last amended by Art. 2 V of 22.02.2006). The maximum marker content in the technical active substance for the procedure of notification is limited to 1 g/kg. The following data or documentation must be submitted:

• code name for the marker
• name of active substance
• registration no. of product(s)
• if the marker is one of the food additives stated which is not yet included in the applicant's positive list, the BVL must also be informed of its identity. A further assessment is not required for such a marker.
• content of the marker in the technical active substance
• analysis methods for the marker in the technical active substance. Methods to determine the marker in representative formulations should be kept available; (only the code name should be used for the marker.)

In the case of a procedure of notification, the marked technical active substance can be used as from its notification for the respective product but is the applicant's personal responsibility. The applicant receives notification of the receipt of the submitted documentation.

Approval procedure

An approval procedure is necessary if the marker is not already in the applicant's positive list accepted by the BfR and UBA, does not belong to the group of food additives stated or its content exceeds 1 g/kg in the technical active substance. For a toxicological and ecotoxicological assessment of the marker by the BfR or UBA, the same confidential documentation which was required for listing the marker must be submitted. Furthermore, the following data/documentation is to be submitted:

• code name for the marker
• name of the active substance
• registration no. of the product(s)
• content of the marker in the technical active substance
• analysis methods for the marker in the technical active substance. Methods to determine the marker in representative formulations should be kept available; (only the code name should be used here for the marker.)

In the case of the approval procedure, the marked technical active substance can only be used following a positive decision by the BVL for the product concerned. If the decision should be negative, the applicant receives a justification for the decision and if necessary a request to submit further documentation.