The table below summarises the legislative criteria relating to human health that must be met in deciding whether to register/not register a formulated pesticide product and/or to approve/not approve a pesticide active ingredient.
Country/region legislation may refer to a pesticide active ingredient as an: active constituent, an active substance or active ingredient. In this table the terminology ‘active ingredient is used in line with the terminology in the Pesticide Registration Toolkit.
Country/region legislation may refer to a formulated product as a: agricultural chemical product, plant protection product or pest control product. In this table the terminology ‘formulated product is used in line with the terminology in the Pesticide Registration Toolkit.
Links to the relevant legislation are provided and should be used as the ultimate reference.
Aspect | Description |
Applicable legislation | |
Legislative criteria - protection goal | The protection goals for human health (the safety criteria) is:
- that the use of the active ingredient or formulated product in accordance with label instructions is not an undue hazard to the safety of people exposed during its handling or people using anything containing its residues; and
- is not likely to have an effect that is harmful to human beings
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Legislative criteria - matters to be taken into account in making a decision | In determining whether the protection goals (safety criteria) are met the decision-maker must have regard to a number of technical matters.
For the active ingredients these include:
- the toxicity of the active ingredient and its residues, including metabolites and degradation products
- the method of manufacture
- the chemical composition of the active ingredient
- the methods of analysis of the chemical composition of the active ingredient
- whether the ingredient conforms to the relevant standard
For the formulated product these include:
- the toxicity of the product and its residues, including metabolites and degradation products
- how the product is formulated and the composition and form of the constituents
- the poisons classification
- method of analysis for the chemical compositor and form of the constituents of the product
- whether the product conforms to a relevant standard
As relevant, the decision-maker must have regard to the following:
- the acceptable daily intake of each constituent in the product
- any dietary exposure assessment
- results of residue trials and compliance with residue limits that are set or will be set
- the stability of the product
- the specifications for containers of the product
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Legislative criteria -decision-making principles | The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is refused. |
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Aspect | Description |
Applicable legislation | |
Legislative criteria - protection goal | The protection goals for human health are to:
- prevent unacceptable risks to human health from the use of pest control products.
- minimize health risks and encourage the development and implementation of innovative, sustainable pest management strategies by facilitating access to pest control products that pose lower risks and by other appropriate measures.
- consider different sensitivities to pest control products of major identifiable subgroups, including pregnant women, infants, children, women and senior
- provide reasonable certainty that no harm to human health, including future generations, will result from exposure to, or use of the product, taking into account its conditions or proposed conditions of registration
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Legislative criteria - matters to be taken into account in making a decision | In determining whether the protection goals are met the decision-maker must have regard to a number of technical matters:
Human Health - methods of analysis for detecting and determining the amount of the pest control product and its derivatives in human food, animal feed and the environment when the product is used in accordance with its conditions or proposed conditions of registration;
- the fate of the pest control product in humans or animals exposed to it, including the identity and quantity of all the major metabolites and other derivatives that result from its use;
- the residues of the pest control product and its derivatives that may remain in or on human food or animal feed after its use in accordance with its conditions or proposed conditions of registration;
- the risks posed to humans or animals exposed to the pest control product or its derivatives through their diet or drinking water when the product is used in accordance with its conditions or proposed conditions of registration;
- the effect of storing and processing, including post-market processing, of human food or animal feed, in relation to which the pest control product was used, on the dissipation or degradation of the pest control product and any of its derivatives;
- the fate of the pest control product and its derivatives in subsequent plantings of crops for human food or animal feed.
- apply a scientifically-based approach to risk assessment (includes establishing an ARfD, ADI, occupational and non-occupational reference values, and q1* as relevant).
- aggregate exposure (dietary exposure and exposure from other non-occupational sources, including drinking water and use in and around homes and schools) and cumulative effects of the pesticide and other pesticides with similar mechanisms of toxicity.
In making a decision about the registration of a pesticide, the decision-maker must, if necessary, specific a maximum residue limit for the pesticide or its components or derivatives.
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Legislative criteria -decision-making principles | The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is denied. |
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Aspect | Description |
Applicable legislation | |
Legislative criteria - protection goal | The protection goals focuses on pesticide operators, bystanders and consumers. |
Legislative criteria - matters to be taken into account in making a decision | Matters to be taken into account in making a decision relate to human health risks including the use of personal protective equipment. |
Legislative criteria -decision-making principles | n.a. |
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Aspect | Description |
Applicable legislation | |
Legislative criteria - protection goal | The protection goals for human health are: - the residues of the formulated product will not have any harmful effects on human health, including that of vulnerable groups taking into account known cumulative and synergistic effect (where there are scientific methods to assess such effects are available)
- the formulated product has no immediate or delayed harmful effect on human health, including that of vulnerable groups, directly or through drinking water, food, feed or air, or consequences in the workplace or through other indirect effects taking into account known cumulative and synergistic effect (where there are scientific methods to assess such effects are available).
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Legislative criteria - matters to be taken into account in making a decision | In determining whether the protection goals are met the decision-maker must have regard to a number of technical matters:
For the active ingredient these include:
- that methods of analysis of the active ingredient and impurities of toxicological concern or which are present at greater than 1g/kg are accurate, precise and validated
- that methods of residue analysis for the active ingredient and relevant metabolites in plant and animal matrices and drinking water are sufficiently sensitive and validated
- a residue definition can be established for the purposes of risk assessment and for enforcement purposes
- that an ADI, ARfD and AOEL are established, as relevant and in doing so a safety factor of 100 (or higher if relevant) should be applied
- that the ingredient is not classified as:
- a mutagen based positive evidence from human epidemiological studies or positive results from certain in vivo tests
- known to have carcinogenic potential for humans or presumed to have carcinogenic potential for humans (unless it can be used in ways that exclude contact with humans eg closed systems)
- a known reproductive toxicant or a presumed human reproductive toxicant (unless it can be used in ways that exclude contact with humans eg closed systems)
- an endocrine disruptor
Further detail on the classification of mutagens, carcinogens and reproductive toxins is provided in Regulation (EC) No 1272/2008
Further detail on the defining endocrine disruptors is provided in Commission Regulation (EU) 2018/605
All of the above requirements that apply to the active ingredient also apply to safeners and synergists.
For residues, analytical methods to measure residues of toxicological or drinking water relevance must be available.
Requirements for the authorisation of formulated products include: - the active ingredient, safener and synergists have been approved and are in accordance with specifications
- the formulated product does not contain certain prohibited co-formulants (specified in Annex III of Commission Regulation (EU) 1107/2009)
- the formulation is designed to limit user exposure and other risks
- the nature and quantity of all ingredients (including toxicologically relevant impurities) can be determined by appropriate methods
- residues resulting from authorised use can be determined by appropriate methods
- the physical and chemical properties are acceptable for the use and storage of the product
- for plants and plant products to be used as feed or food, the maximum residue levels for the agricultural products affected by the use have been set in accordance with Regulation (EC) No 396/2005
- recognised tests and analyses should be used and carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in questions and representative of the conditions prevailing the the zone where the product is intended to be used
- interaction between the active ingredient, safeness, synergists and co-formulants shall be taken into account in the evaluation
Further detail on the evaluation principles are provided in Commission Regulation (EU) No 546/2011 |
Legislative criteria -decision-making principles | The decision-maker must register the pesticide if administrative requirements and human health and environmental criteria are met.
Specific decision-making principles apply:
In relation to the impact on human health arising from the pesticide the decision-making principles are: - if operator exposure exceeds the AOEL, authorisation cannot be granted
- risk mitigation measure such as protective clothing and equipment must be practical in the climatic conditions, effective and readily obtainable by the user
- waiting and re-entry periods must be realistic
- pesticides that meet certain toxicity thresholds cannot be authorised for non-professional users
In relation to impact on human health from residues: - residues occurring reflect the minimum quantities of pesticide necessary and applied such that that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum
- evidence that the recommend use will not exceed the MRL
- risk assessment based on worst-case potential exposure of consumers
- taking into account all registered uses, the proposed use shall not be authorised if the best possible estimate of dietary exposure exceed the ADI
- a separate risk assessment may need to be carried out where processing has an impact on residues
Further detail on the decision-making principles are provided in Commission Regulation (EU) No 546/2011 |
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Aspect | Description |
Applicable legislation | |
Legislative criteria - protection goal | The protection goal for human health is: - that the pesticide will perform is intended function without unreasonable adverse effects* on the environment and when used in accordance with widespread and commonly recognised practice will not generally cause unreasonable adverse effects on the environment.
- No harm will result from aggregate exposure to pesticide residues including all anticipated dietary exposures and all other exposures for which there is reliable information.
- No harm will result to infants and children from aggregate exposure to pesticide residues.
* Unreasonable adverse effects on the environment is defined as ‘any unreasonable risk to man or the environment, taking into account the economic, social and environmental costs and benefits of the use of the pesticide’. |
Legislative criteria - matters to be taken into account in making a decision | |
Legislative criteria -decision-making principles | The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is denied. |
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The overarching human health protection goals, embedded in legislation, require a high level of protection of humans. These protection goals are similar across regulatory frameworks and can be applied in any country.
Country and region legislative frameworks differ in how they set out registration criteria. Some frameworks are very specific in what matters to consider and, in some cases, how they are to be considered. Legislation from different countries/regions may:
- emphasise the protection of vulnerable groups, infants and children and/or future generations;
- set out specific scientific matters that need to be considered;
- set hazard-based criteria for active ingredients as the first tier of assessment and decision-making;
- require aggregate exposure, cumulative and synergistic effects to be considered;
- require the setting of toxicological reference values and/or the use of safety factors; and/or
- set out uniform principles for evaluating and making decisions where multiple agencies/countries are involved in the evaluation and decision-making.
The matters to be mandated through legislation is a policy question and for each country/region to decide. Some countries recognise that describing detailed evaluation and decision-making criteria in manuals and guidelines offers greater flexibility and the ability to more quickly adopt new policy and scientific developments.
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