Approval of active substances used in plant protection products

Active substances used in PPPs are evaluated by the Member States and the European Food Safety Agency (EFSA). When the evaluation is completed, EFSA issues an opinion on the assessment and approval of an individual active substance and submits it to the European Commission. Based on this opinion, the European Commission drafts a proposal on the approval or non-approval of the substance and puts it on the agenda of meetings of the Standing Committee on Plants, Animals, Food and Feed – “Plant Protection Products – Legislation”. Member States vote on the proposal at the Committee meeting. After the adoption of the proposal, the European Commission publishes a regulation on the approval or non-approval of the active substance for the EU area in the Official Journal of the EU. The data on approved and non-approved active substances are published in the EU pesticides database. 

An applicant wishing to obtain an approval of an active substance in the EU must submit extensive documentation – dossier to one of the EU Member States. The procedure of assessment of active substances involves the Administration for Food Safety, Veterinary Sector and Plant Protection (Administration). If an applicant wishes to submit an application for the assessment of an active substance in Slovenia, they can contact the Administration. 

An active substance is approved for the period of 5 to 15 years, in respect of the properties of the active substance. The manufacturer of the active substance must submit an application for the renewal of approval to a specific Member State at least three years before the expiry of the approval. To this end, the European Commission adopts a regulation establishing an action plan listing the rapporteur Member States for each individual active substance. 

Authorisation of plant protection products

The first condition for a PPP authorisation is the approval of an active substance or substances contained in the PPP in the EU.

The authorisation of a PPP includes an evaluation of the risk of a PPP to human health, animal health and the environment, the identification of measures to reduce the PPP risk and the conduct of the administrative procedure regarding the application for the authorisation of a PPP. 

The risk is evaluated according to the following:

• physical-chemical properties of a PPP and analytical methods,
• toxicology including risk assessment for the person who performs treatments, workers, bystanders and residents, 
• toxicology in the field of PPP residues in food and feed,
• ecotoxicology,
• fate and behaviour of a PPP in the environment,
• efficacy and other data related therewith.

The assessment follows the uniform principles for assessment and authorisation of plant protection products.

An applicant may submit an application for a PPP authorisation by different procedures:

1. Application for zonal authorisation of a plant protection product (PPP)
2. Application for mutual recognition of authorisation for a plant protection product (PPP)
3. Application for the extension of authorisation of a plant protection product (PPP)
4. Application for a change or withdrawal of a plant protection product (PPP)
5. Application for a renewal of authorisation for a plant protection product (PPP)

After completing the risk assessment of a PPP to human health and the environment, the Administration adopts the final decision on the use of a PPP in the territory of Slovenia in agreement with the Chemicals Office of the Republic of Slovenia.

After the decision on the authorisation of a PPP has been issued, the PPP is entered in the Fito-Info registered plant protection product database, which also contains thematic lists.

Comparative assessment of plant protection products

For plant protection products (PPPs) containing active substances that are candidates for substitution, Member States are required, when assessing an application for authorization, to evaluate if they can be replaced by other appropriate chemical or non-chemical methods.

List of candidate active substances for substitution.

Instructions for preparing documentation for comparative assessment:

Applicants for the authorisation of such PPPs in Slovenia have to submit additional documentation in their applications, enabling comparative assessment. The template for the comparative assessment with instructions is prepared in English.

European Union zones for the authorisation of plant protection products

To reduce administrative burdens for applicants submitting applications for the authorisation of a PPP in several Member States, the EU legislation divided the EU in three zones: North, Central and South. An applicant may submit an application for the authorisation of a PPP in several states of the same zone (or in several zones), but it is assessed by one Member State for all states in the zone where the application was submitted. The Member State assessing the application is called a zonal rapporteur. After the assessment is completed, the zonal rapporteur drafts the assessment report on the basis of which the PPP is authorised by other Member States in their respective territories. 

The process of examining an application for the recognition of authorisation is compulsory for Member States in the same zone; if the recognition of authorisation of a PPP from a Member State from another zone is needed, a Member State may voluntarily opt for this procedure. If the Administration does not accept a procedure of recognition of authorisation of a PPP from another zone for certain reasons, an applicant may submit an application for the zonal authorisation of a PPP. The Administration plays an active part in the procedure of zonal authorisation of a PPP, also in the role of zonal rapporteur.

Definition of zones for the authorisation of plant protection products

1. Zone A – North: Denmark, Estonia, Latvia, Lithuania, Finland, Sweden
2. Zone B – Central: Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, the Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom
3. Zone C – South: Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal, Croatia

For the authorisation of PPPs to be used in greenhouses, in after-harvest treatment, treatment of empty warehouses or containers or seed treatment, all EU Member States are considered a single zone. For these uses, a single Member State assesses an application for the entire EU area.

Permits for plant protection products

An applicant may apply for three types of permits related to the placing on the market or use of a PPP:

1. A plant protection emergency authorisation permit may be issued under special circumstances due to the occurrence of pests for the maximum period of 120 days for limited and controlled use of PPPs where such a measure appears necessary because of a danger that cannot be controlled by any other reasonable means. Such permit is issued based on an application submitted by an applicant. 
2. PPP research and development permit is issued for tests and trials involving PPPs for research and development purposes, which include the release of an unauthorised PPP in the environment or an unauthorised use of a PPP. A permit is issued based on an application submitted by an applicant. PPP efficacy trials for obtaining documentation for the authorisation of a PPP are performed by entities designated to perform efficacy trials by decision issued by the Administration. The decision on designation is issued based on an application submitted by an applicant. 
3. A parallel trade permit for PPPs is aimed at increasing the accessibility of PPPs on the markets of smaller Member States not attractive for major PPP manufacturers because of a small sales volume, and the levelling of PPP price differences on the markets of the Member States. The condition is that the PPP is registered in Slovenia and another Member State for the same or similar use related to plant protection, and that it will be used as permitted in Slovenia. A parallel trade permit for PPPs is issued based on an application submitted by an applicant.

Good experimental practice in implementing efficacy trials of plant protection products

PPP efficacy tests ordered for obtaining the documentation for the authorisation of a PPP shall be implemented by standard operation procedures that are established by the entity performing trials for regular monitoring and recording of all trial-related events and that enable correct processing of obtained data. 

Field trials of PPP efficacy are conducted in accordance with the latest published guidelines of the European and Mediterranean Plant Protection Organisation (EPPO).

An entity performing PPP efficacy trials that wants to obtain a decision on designation submits an application for the designation of an entity performing efficacy trials to the Administration. The Administration appoints a commission that examines the application and attached documentation and carries out a site visit if necessary. The commission draws up a report and if its opinion is positive, a decision on the designation of an entity performing efficacy trials is issued for a five-year period. Prior to the decision's expiry, an entity performing PPP efficacy trials may submit another application for the designation of an entity performing PPP efficacy trials. 

The following institutions have been designated to perform the PPP efficacy trials for obtaining documentation for authorisation of PPPs in Slovenia:

• Slovenian Institute of Hop Research and Brewing,
• Agricultural Institute of Slovenia,
• Institute of Agriculture and Forestry Maribor,
• Eurofins Agroscience Services Austria GmbH.

Packaging and labelling of plant protection products

An applicant or authorisation holder must classify, label and package PPPs in accordance with the legislation governing classification, labelling and packaging of chemicals. 

In addition to this labelling, an applicant labels PPPs by additional standard sentences about particular hazards for humans, animals or the evnironment, and by standard sentences for safety measures for the protection of humans, animals or the environment. The Administration determines the sentences that an authorisation holder should add to the label in the PPP authorisation procedure.  

PPPs on the market in the Republic of Slovenia must have a label and instructions for use in Slovenian.

In Slovenia, PPPs classified as hazardous for bees have an additional bee hazard sign. The list of PPPs hazardous for bees is published in the search engine of PPPs authorised in Slovenia.