New Law on Phytopharmacy in North Macedonia

New Law on Phytopharmacy in North Macedonia

North Macedonia
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It is no secret that North Macedonia is facing the issue of usage of products for plant protection which often fail to meet legal standards. Namely, Macedonian manufacturers producing agricultural products for human and animal nutrition often use unauthorized products which fail to meet safety criteria and may have suspicious origins. Although this issue is not as widely-discussed as air pollution in North Macedonia, it contributes significantly to the existing environmental pollution problem and has a huge impact on the health of plants, people, and the environment.

In addition to poor ecological awareness, lower prices, and an “aggressive efficiency” justification, one of the reasons for this practice is the failure of North Macedonia’s current Law on Products for Plant Protection to tackle the issue. The current law is ineffective for several reasons, the main one being a poor system for control of the products for plant protection imported into the country. 

This matter has already been identified by some NGOs and the trade organizations in the past and passed along to the Macedonian Ministry for Agriculture, Forestry and Water Economy. As a result, a new Law on Phytopharmacy is expected soon. 

The new draft Law on Phytopharmacy has been approved by the Macedonian Government, and once adopted by Parliament, it will partially harmonize the legislation with EU acquis, either by direct implementation (e.g., the transposition of Regulation 1107/2009 on placing and advertising of phytopharmaceutical products and Directive 128/2009 on sustainable use of pesticides) or by providing the basis for indirect harmonization with other EU legislation (e.g., the regulation on collecting phytopharmaceutical usage data, marking phytopharmaceutical products, monitoring programs, using equipment for application of phytopharmaceutical products). The harmonization with the EU regulatory framework will be made only partially though, as some provisions in the EU code apply only to member states and will be transposed into North Macedonian law once the country becomes a member state, or is in a more advanced phase of accession.

Overall, the new Law on Phytopharmacy is expected to assure greater protection of plants and further regulation and control of the use of pesticides and the application of non-pest control measures, which should ultimately result in a higher level of protection of human and animal health and overall environmental protection.

The expectation for the higher efficiency of the new Law on Phytopharmacy is based on the following elements: (i) a more sophisticated regulation of the import, packaging, labelling, advertising, and placing on the market of products for plant protection (identified as phytopharmaceutical products under the new Law on Phytopharmacy); (ii) continuous monitoring of food safety, including animal food, in the chain of plant production; (iii) mandatory training and licensing of all legal entities and professional users of pesticides, as well as controlling, testing, and certifying of equipment for use on phytopharmaceutical products; (iv) introducing a phytosanitary information system electronically connected to all users that will enable the mandatory recording of the sale (by the legal entities) and the use (by the users) of phytopharmaceutical products; (v) a more detailed regulation of the emergency approval process for phytopharmaceutical products, as well as stricter rules for import of phytopharmaceutical products via border crossing points with access to adequate control facilities; and (vi) the placing of phytopharmaceutical products containing GMO and other living organisms on the market only if the product fulfils the conditions in the GMO regulation.

By implementing these mechanisms, the authorities will have oversight and control of the import, sale, and use of phytopharmaceutical products and the equipment for their application, and they will be able to better educate all people that have contact in any manner with pesticides. Once the import and placement of phytopharmaceutical products on the market is harmonized with EU standards, the quality and the safety of the products should increase, and the placement of unauthorized phytopharmaceutical products on the market should be prevented. 

Although there is no information on when the new Law on Phytopharmacy will be adopted by the Parliament, we hope that the urgent need for the law will be recognized by the Parliament and that North Macedonia will soon be able to reach EU standards in this area.

By Marija Filipovska, Partner, CMS North Macedonia

This Article was originally published in Issue 6.6 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.