Regulation (EU) No 528/2012 has been in force since 01.09.2013; it applies to the whole of the EU and replaces the biocides directive which was previously in force (Directive 98/8/EC). Amongst the new changes which were introduced with this regulation is the setting of maximum residue limits.

Article 19 (1) e states the regulations of the European Union in which maximum residue limits can be set if needed. This includes Regulation (EC) No 396/2005. Setting a maximum residue limit, provided that this is necessary, is a prerequisite for authorisation.

According to Article 19 (7) it is the applicant's responsibility to apply for a maximum residue limit for biocidal products if this is required. Regardless of the extent to which this is required, the following should be noted:

• The maximum residue limits stated in Regulation (EC) No 396/2005 apply to all active substances which are listed in the EU Commission database for plant protection and which are also used in biocidal products. Please see the link below for this database.

• If an active substance is not subject to Article 18 (1) of Regulation (EC) No 396/2005 (a standard value of 0.01 mg/kg applies in this case) or is not listed in Annex IV (it is not necessary to set a maximum residue limit here), the current values can be found in the Commission database stated above.

The Federal Office of Consumer Protection and Food Safety (BVL) is responsible in Germany for the process of setting maximum residue limits according to Regulation (EC) No 396/2005. Applications for setting maximum residue limits for active substances in biocidal products are therefore also sent to the BVL, who in turn informs the Federal Institute for Occupational Safety and Health (BAuA).

An application procedure for setting maximum residue limits for biocidal products in Germany is currently being developed by the authorities involved, taking into consideration the individual aspects and tasks resulting from the new biocides regulation. The BVL will provide a corresponding application form on its website in the near future. For the meantime no special form is required for submitting an application.

Ideally, an application for maximum residue limits should be placed straight after an approval has been made public or together with the application for authorisation for the biocidal product. Should the necessity to set a maximum residue limit become evident during the assessment of the application for authorisation, the applicant will be informed and requested to submit a corresponding application for a maximum residue limit. However, in this case it cannot be guaranteed that the required maximum residue limit can be made public and will be in force in time to meet the delivery deadline (according to Article 89 (2) of Regulation (EU) No 528/2012).

Further general information and a glossary regarding residues on food are available on the BVL website; the respective pages are stated below. Please note that these articles were written with plant protection products in mind and are not fully applicable to biocidal products.