Regulation on the Licensing and Placing on the Market of Plant Protection Products

The Regulation on the Licensing and Placing on the Market of Plant Protection Products was prepared by the Ministry of Agriculture and Forestry and published in Official Gazette No. 32489 of 14 March 2024. It governs the studies on which a licence is based, the licensing, classification, packaging, labelling and placing on the market of plant protection products in commercial form for use against harmful organisms, and the obligations of licence applicants and licence holders (Article 1). It entered into force on the date of publication (Article 57) and repealed both the Regulation on the Classification, Packaging and Labelling of Plant Protection Products (Official Gazette No. 27885 of 25 March 2011) and the earlier licensing regulation (Official Gazette No. 30235 of 9 November 2017) (Article 56).

Which products and persons does the Regulation cover?

Its scope covers licensing requirements and the rules on classification, packaging, labelling and placing on the market, without prejudice to the Regulation on the Classification, Labelling and Packaging of Substances and Mixtures. Certain products derived from genetically modified organisms and micro-organisms based on gene-editing techniques are outside its scope unless the Biosafety Law provides otherwise (Article 2).

Legal entities that wish to obtain a licence must first obtain the Plant Protection Products Business Permit issued by the Ministry (Article 5). Placing on the market and using plant protection products that have not been licensed by the Ministry is prohibited; no licence is needed for research and development use (Article 30).

When is a licence suspended or cancelled?

A licence is suspended in cases such as where the business permit is suspended or cancelled and is not renewed within three months, or where requested information and documents are not submitted on time (Article 27). If the reason for suspension is not removed within six months, the licence is cancelled without further warning (Article 28).

Article 28 lists other grounds for cancellation: submission of forged or irregular documents, a licensed product not being produced, or imported and placed on the market, for three years, failure to apply for extension of the licence validity period, repeated non-conformity with the formula and specification on which the licence was based, and situations that require cancellation under the control legislation. If an international body ends the use of an active substance because of its risks to human or animal health or the environment, the licences for all formulations of that substance are deemed cancelled.

What happens to the stocks of a product whose licence is cancelled?

When the Ministry cancels a licence, modifies a licensed product or does not renew a licence, production and import are stopped. Where it considers it necessary, the Ministry grants an additional period for the disposal, storage, marketing and consumption of existing stocks (Article 29).

If the reasons are not related to protecting human or animal health or the environment, the additional period is at most six months for selling and distributing stocks and at most one year for their disposal, storage and use. Products whose licence was cancelled because its validity period was not extended may remain on the market until their expiry date if they were produced or imported before the date of cancellation (Article 29).

What does it mean for destruction and recycling?

The provision that links the Regulation directly to destruction is Article 30: even if licensed, a plant protection product that is past its expiry date may not be placed on the market or kept at dealers, and recalling such products from the market and destroying them is the responsibility of the licence holder. The return, recall and destruction periods that apply at the dealer, wholesaler and warehouse stage are set in a separate regulation, the one on sale and storage.

On packaging, the Regulation lists, among the warnings that may appear on the label, the phrase “dispose of empty packaging properly” (Article 35). The licence file also contains methods for the destruction of the product and its packaging, and these are excluded from confidentiality (Article 52). The Regulation does not set up a separate recycling system for packaging waste.

What should be watched in practice?

A licence holder should monitor the periods set in Article 30 for placing a licensed product on the market, because the licence may otherwise be cancelled. When a licence is transferred, all responsibility for it stays with the licence holder recorded in the Ministry’s records until the Ministry completes the transfer (Article 26).

For stock management, tracking expiry dates and grace periods is necessary so that recalled products are routed to documented destruction. This Regulation sets the framework for licensing and placing on the market; the return and destruction obligations at the dealer, wholesaler and warehouse stage should be read together with the regulation on sale and storage.