Regulatory assessment of health and safety for plant protection products

The impact of a plant protection product on human health and safety is assessed before market introduction and subsequently on a regular basis in periodical re-evaluations.

Plant protection products must be approved by the appropriate national regulatory authorities before they can be placed on the market in the individual countries. The approval process is laid down in national laws or regulations and includes an assessment of impact on human health and safety. Plant protection products can not be approved unless it can be shown, that the products can be used safely by the farmers or growers, and unless it can be shown that residues on treated crops are not harmful for consumers.

When applying for approval of a plant protection product the applicant must provide the regulatory authorities with sufficient documentation to allow for a comprehensive evaluation of the product. The documentation must address the physical and chemical properties, the toxicological properties, residues in treated crops and also documentation for potential side effects on the environment. The level and volume of the required documentation is substantial and it is in many ways similar to the requirements for approval of pharmaceutical products. The applicant must conduct standard toxicology studies in order to address health and safety of the plant protection product. The studies must be conducted according to internationally agreed test guidelines (e.g. the OECD test guidelines) and the studies must be conducted in compliance with the requirements for Good Laboratory Practice (GLP).

If a country does not have sufficient resource to carry out their own review, they may instead require that the product is already approved in an OECD country, where it has been thoroughly evaluated.

Most countries will carry out periodical reviews of plant protection products, e.g. every 5 or 10 years, and may require the registrants to provide updated documentation in order to meet the current scientific and regulatory standards. In case a plant protection product is suspected to have unwanted effects, the regulatory authorities may decide to initiate a special review and may call for additional documentation. As a result of the re-evaluation process, the registrant may be required to change the product composition or to change the use pattern or the requirements for personal protective equipment in order to avoid unacceptable risk.

Risk indications and safety precautions must appear on the label of a plant protection product, and the label text must always be in compliance with national legislation.

Plant protection products are, like other chemical products, classified for health effects according to their properties, e.g. according to the Global Harmonised System for classification and labelling.

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