Pesticides, Laws and Permits

Published in Poisons Beware

This is a guide to the systems governing chemical pesticide regulation, registers and laws, with an overview of some of the many problems arising from pesticide use.

Use the links and references in the article to check on the current situation in official sources. For a list of chemical pesticides commonly used on Hvar and elsewhere in Croatia, including their scientifically proven possible adverse effects, please see our article 'Pesticides and their adverse effects'.

WHAT YOU NEED TO KNOW

Chemical pesticides are used in massive quantities around the world. The World Health Organisation (WHO) has expressed concern about Pesticide residues in food (February 2018) : 
  • Pesticides are potentially toxic to humans and can have both acute and chronic (long-term) health effects, depending on the quantity and ways in which a person is exposed.
  • Some of the older, (often cheaper version) pesticides can remain for years in soil and water. These chemicals have been banned from agricultural use in developed countries, but they are still used in many developing countries.
  • People who face the greatest health risks from exposure to pesticides are those who handle them or come into contact with them at work, in their home or garden.

As is recognized in Regulation (EU) No 528/2012 : "biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns." Information about potential hazards and long-term effects is vital for all those involved in the manufacture of pesticides, all those who handle pesticides in the marketplace, all those who use pesticides in fields or gardens - and all the consumers who buy products of any kind which have been treated with pesticides. In short, everyone needs to understand all the issues at stake in relation to pesticides.

EXCERPTS FROM THE EUROPEAN LAWS & REGULATIONS GOVERNING PESTICIDES

The words are fine, but how many of the worthy principles enshrined in law are honoured in practice?

1. THE RIGHT TO KNOW

"EU citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in the Agency's database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures." (Regulation (EC) No 1907/2006 Introduction. clause 117)

"Every European citizen has the right to know how the food they eat is produced, processed, packaged, labelled and sold." (European Commission, Food Safety)

2. THE PRECAUTIONARY PRINCIPLE

In European law: "The precautionary principle is an approach to risk management, where, if it is possible that a given policy or action might cause harm to the public or the environment and if there is still no scientific agreement on the issue, the policy or action in question should not be carried out. However, the policy or action may be reviewed when more scientific information becomes available. The principle is set out in Article 191 of the Treaty on the Functioning of the European Union (TFEU)."

"The concept of the precautionary principle was first set out in a European Commission communication adopted in February 2000, which defined the concept and envisaged how it would be applied.

The precautionary principle may only be invoked if there is a potential risk and may not be used to justify arbitrary decisions. Examples of where the EU has applied the precautionary principle include its regulatory framework for chemicals (Regulation (EC) No 1907/2006 — known as REACH) and the general regulation on food law (Regulation (EC) No 178/2002)."

3. REGISTRATION AND AUTHORIZATION OF PESTICIDES

i) Biocidal substances and products

Regulation (EC) No 1907/2006 covered the Registration, Evaluation, Authorisation and Restriction of Chemicals (known as REACH) and the establishment of the European Chemicals Agency (ECHA), while amending and repealing various previous Directives and Regulations. This Regulation came about because of "a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle" (Introduction, item 9).

Basic principles enshrined in Regulation (EC) No 1907/2006:

"This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle." (Regulation (EC) No 1907/2006: Title 1, Chapter 1, Aim Scope and Application, article 1, 3.)

Regulation (EU) No 528/2012: "Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns."

Biocidal products are authorized in two stages, firstly by evaluation of the toxic active ingredients, then by approval of the product itself. The second stage, according to the ECHA information on biocides: "All biocidal products containing approved active substances are evaluated for safety and efficacy before they are allowed to be sold in the EU. However, products that were on the market before 2000 can continue to be sold while the authorities are evaluating the active substances they contain."

ECHA: Understanding BPR [biocidal products regulations] "All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted."

ECHA: Approval of active substances: "Active substances need to be approved before an authorisation for a biocidal product containing them can be granted. The active substances are first assessed by an evaluating Member State competent authority and the results of these evaluations are forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as the basis for the decision on approval which is adopted by the European Commission. The approval of an active substance is granted for a defined number of years, not exceeding 10 years and is renewable. The BPR introduces formal exclusion and substitution criteria which apply to the evaluation of active substances.

    1. Exclusion criteria
In principle, active substances meeting the exclusion criteria will not be approved .
This includes:
  • carcinogens, mutagens and reprotoxic substances categories 1A or 1B according to the CLP Regulation
  • endocrine disruptors
  • persistent, bioaccumulative and toxic (PBT) substances
  • very persistent and very bioaccumulative (vPvB) substances"
BUT: "Derogations are foreseen, in particular when the active substance may be needed on the grounds of public health or of public interest when no alternatives are available. In this case, approval of an active substance is granted for a maximum of five years (also for active substances where the assessment report was submitted before 1 September 2013, as per the transitional provisions)."
    1. "Active substances which are candidates for substitution

The objective of this provision is to identify substances of particular concern to public health or the environment and to ensure that these substances are phased-out and replaced by more suitable alternatives over time.
The criteria are based on the intrinsic hazardous properties in combination with the use. An active substance will be considered as a candidate for substitution if any of the following criteria are met:
  • It meets at least one of the exclusion criteria.
  • It is classified as a respiratory sensitiser.
  • Its toxicological reference values are significantly lower than those of the majority of approved active substances for the same product-type and use.
  • It meets two of the criteria to be considered as PBT.
  • It causes concerns for human or animal health and for the environment even with very restrictive risk management measures.
  • It contains a significant proportion of non-active isomers or impurities."

ii) 'Plant protection' substances and products

The European Commission, which is responsible for Food Safety, sets out the conditions for the Approval of active substances: "The Member States, the European Food Safety Authority (EFSA) and the Commission evaluate every active substance for safety before it can be placed on the market and used in a plant protection product. At least one use of the substances in plant protection products must be proven safe for people's health, including their residues in food, for animal health and must not have any unacceptable effects on the environment before a substance can be approved, where relevant subject to conditions or restrictions."

PESTICIDES IN THE FOOD CHAIN

"Every European citizen has the right to know how the food they eat is produced, processed, packaged, labelled and sold." (European Commission: Food Safety). This should mean that all chemical pesticides used at any stage of production should be openly declared for the consumer to see. In practice this does not happen.

Chemical pesticides are a lucrative business, promoted through powerful marketing and political clout. Pesticide control is complicated at international, national and local levels. Public information is vital. Pesticide vendors and users should be fully aware of what they are dealing with. Consumers, the end-users, need to be told what substances have been used in the production and packaging of foodstuffs and personal hygiene products. When pesticides are approved for the market, the first area of concern is that the safety and efficacy studies which support an application are produced by the commercial companies: these are usually unpublished papers, whereas independent studies published in peer-reviewed journals are hardly, if ever, taken into account. On approval, for pesticides which are likely to enter the food chain, so-called 'safe' levels are established as the maximum amounts which can be present in crops and foodstuffs without jeopardizing health. The 2015 report produced by the United States Department of Agriculture (USDA) revealed that only 15% of 10,187 sample foodstuffs tested were free of pesticide traces, while over 99% contained residues, albeit below the tolerances established by the U.S.Environmental Protection Agency (EPA). The European Food Safety Authority (EFSA) reported that of 84,657 samples tested in 2016, 96.2% were within the limits set by EU legislation and 50.7% were free of quantifiable residues, while legal limits were exceeded in 2.4% of the samples from EU and EEA countries, and 7.2% from non-EU countries.

Are Maximum Residue Levels (MRLs) a guarantee of safety? There are drawbacks: 1) MRLs do not cover the effect of a combination of poisons in foods, if, as is usual, 'conventional' crops have been treated with several different types of pesticide; 2) inspections in different countries (eg Kuwait) all too often discover pesticide residues above permitted levels, not to mention banned pesticides, in foodstuffs (eg Denmark, 2017); 3) MRLs have an alarming tendency to be raised, quite often for marketing reasons, as with glyphosate in 2013, and lasaloocid in 2015; 4) it is worrying that commercial pesticide manufacturers can ask for MRLs to be raised, eg Syngenta's request in 2012 for a significant increase in permitted levels of neonicotinaoid insecticide residues in olives, artichokes and cauliflower (EFSA Journal 10 (11) 2990); 5) on one hand it is good that the setting of MRLs is reviewed periodically, as in the EFSA paper 'Scientific opinion on pesticides in foods for infants and young children' (EFSA Journal, May 2018), but on the other hand this brings the worry that MRLs in infant foods were incorrectly set for years previously. 

Contamination of water sources and therefore drinking water by pesticides is another major area of concern, for which the World Health Organisation has drawn up widereaching guidelines. The EU has Directives governing drinking water quality, while in the United States the EPA has set more specific Maximum Contamination Levels for different kinds of pollutants. On the ground, pesticide users must be aware of the dangers of groundwater contamination, not only when applying pesticides, but also when disposing of excess or outdated poisons and discarding pesticide packaging. 

PESTICIDE REGISTERS

The European Chemicals Agency (ECHA) lists approvals of active biocidal substances and products. Its website is the primary source of information about the laws and regulations governing biocidal pesticides and their approval processes. You can check its list of substances which are approved or under review, or you can check on active ingredients and approved products on the ECHA 'biocidal products' page, by typing the name of the active ingredient in the box marked 'Active Substance Name' or the name of a pesticide product in the box marked 'Product Name'. The listing is updated regularly. Herbicides and agricultural fungicides are not included in this listing because they are classified as 'plant protection' products.

The European Commission: The EU Pesticides Database lists 'plant protection' active substances and permitted residual levels in foodstuiffs.

The EPPO (European and Mediterranean Plant Protection Organization) compiles a Listing of national databases of 'plant protection' pesticides

The Ministry of Agriculture, Republic of Croatia: Lists Registered 'Plant Protection' Products. It used to include a section on substances which are no longer approved, listed by year, but this is no longer available in 2021.

The Ministry of Health controls and compiles a Register of biocidal products which can be marketed in Croatia - Registar biocidnih pripravaka - ožujak 2021 (this is in Croatian only, in document form, it is not a database). In 2016, the Ministry of Health issued a list of pesticides which were allowed to be released in the Croatian market up to September 1st 2015 (NN 15/2016, link in Crioatian). Applications to be included in the current register are made to the Ministry of Health. Be warned: products may be listed which are not fully authorized in the EU, although they may still be allowed for use under the extraordinary loopholes in the ECHA regulations (see the excerpts from EU laws and regulations below). For instance, the 2021 list includes products that are not approved by the European authorities (EU, ECHA), such as Neopitroid Premium and Permex 22E - see our article 'Pesticide Products in Croatia' for more details.

The Croatian Institute of Toxicology and Anti-doping: About the Institute. The Institute collects data, advises the Ministry of Health, and carries out educational training programmes on matters relating to poisonings.

University of Hertfordshire: Pesticide Properties Database (PPDB) - database listing pesticide chemical identity, physicochemical, human health and ecotoxicological data.

University of Hertfordshire: Bio-Pesticide Database (BPDB) - database of data relating to pesticides derived from natural substances.

PubChem Open Chemistry Database. U.S. National Library of Medicine, National Centre for Biotechnology Information. Comprehensive technical information about chemical substances, including toxicity.

List of banned pesticides by active substances, and pesticide watchlist (2015), UTZ Amsterdam, the Netherlands

United States of America: the Pesticide Action Network (PAN) launched Pesticide Info, a register of pesticides used in the USA, together with details of toxicity and authorizations, in April 2021. The search options allow you to check chemical active ingredients or named products.

United States National Library of Medicine: Toxnet. Databases on toxicology, hazardous chemicals, environmental health  and toxic releases.

United States Environmental Protection Agency (EPA): Pesticide Registration, Inert Ingredients Overview and Guidance.

OFFICIAL PROCEDURES GOVERNING PESTICIDE REGISTRATION AND USE IN CROATIA

European Commission: Approval of Active Substances (EU link concerning 'plant protection' products)

European Chemicals Agency : Authorization of biocidal products

Food and Agriculture Organization of the United Nations (FAO): Prevention and Disposal of Obsolete Pesticides.

The Croatian Agriculture Ministry is the main coordinator for registering 'plant protection' pesticides and issuing permits for them. Documentation is checked for completness, and then submitted to one of the two registered authorities / institutions named below for a document and risk assessment. This authority may then ask for further documented evidence and information. Communications with the applicant are coordinated through the Agriculture Ministry. When the documentation is satisfactory, the registered authority submits its proposal for registration to the Agriculture Ministry for enactment.

The Croatian Centre for Agriculture, Food and Rural Affairs (as of 1st January 2019 the Croatian Agency for Agriculture, Food and Rural Affairs): Institute for Plant Protection. This Institution department evaluates active ingredients and substances in pesticides and their efficacy, establishes analytical methods, studies pesticide residues in foods and the behaviour of pesticides in the environment, ecotoxicology, and assesses the exposure of operators, workers and others involved in pesticide use.   

Institute for Medical Research and Occupational Health. This Institute at the request of the Ministry of Agriculture prepares documentation for pesticides regarding registration, obtaining certain permits, extending registrations, and expanding registration for small-scale operations. it also provides scientific opinions on mammal toxicology and exposure risks for operators, workers and others involved in pesticide use.  

The Croatian Ministry for Environmental Protection and Energetics is responsible for creating conditions for sustainable development, including "tasks related to protection and conservation of the environment and nature in line with the sustainable development policy of the Republic of Croatia, as well as tasks related to water management and administrative and other tasks from the field of energy." Although soil, air, water and sea quality lies within its remit, it does not include specific projects relating to pesticides.

FURTHER SOURCES OF ADVICE ON PESTICIDE USE IN CROATIA

Hrvatska polioprivredno-šumarska savjetodavna služba (Croatian Agriculture and Woodland Advisory Service): 'Plant protection' (in Croatian)

Agroklub: Pesticides. A selective database of pesticides available in Croatia (in Croatian); no adverse effects listed; the list may not be totally up to date. The list of Agroklub partners iincludes several agrochemical companies.

INTERNATIONAL REGULATIONS GOVERNING PESTICIDE USE

EU LAWS:

European Chemicals Agency: REACH (Registration, evaluation, Authorisation and Restriction of Chemicals) - an explanation

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

 
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (Text with EEA relevance)
 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance

Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ Text with EEA relevance

Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals Text with EEA relevance

Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC

Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Text with EEA relevance. )

Corrigendum to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018)

CROATIAN LAWS

Ministarstvo poljoprivedbe RH: Propisi - Sredstva za zaštitu bilja; ostaci pesticida; održiva uporaba pesticida; zdravstvena zaštita bilja.  Croatian Agriculture Ministry: Regulations governing 'plant protection' products; pesticide residues; sustainable use of pesticides; plant health protection (in Croatian)

Ministarstvo zdravstva zakonodavstvo: Ministry of Health (website in Croatian only).  Laws governing chemicals and biocidal substances; import and export of dangerous chemicals; disease prevention; preventive disinfection, insect and vermin suppression measures; and safety in the workplace.

Ministarstvo zdravstva RH: Kemikalije i biocidni pripravci - Croatian Ministry of Health: Chemicals and Biocidal Products, regulated according to EU laws (website in Croatian only)

Ministarstvo zaštite okoliša i energetike RH; Propisi i međunarodni ugovori. Croatian Ministry for Environmental Protection and Energetics: Regulations and International Contracts: environmental protection; air quality protection; climate and ozone layer protection; waste management; nature protection; sea and coastal region protection (in Croatian)

Croatian Institute for Public Health: Laws and Regulations. Laws (in Croatian) relating to the prevention of transmissible diseases include the use of pesticides.

© Vivian Grisogono 2018, updated 14th September 2021

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