PIP SUMMARY OF EU PESTICIDE REGULATIONS

Up to 14 June 2011, the evaluation, marketing and use of pesticides (herbicides, insecticides, fungicides etc.) in plant protection in the European Union was regulated under Council Directive 91/414/EEC.

This Directive lays out the procedure that must be used for the risk assessment and approval of new and existing active substances, as well as products containing them.

Before a pesticide active substance can be marketed and used in the EU, it must pass through an authorisation process and be officially approved for use. To be approved, each active substance (whether new or existing) has to be proven safe in terms of human health, residues in the food chain, animal health, and the environment. It is the responsibility of the plant protection industry to provide the necessary data which demonstrates that a substance can be used safely.

The first step of the evaluation process is conducted by a Rapporteur Member State. The outcome of their evaluation is transmitted to the European Food Safety Authority (EFSA), which then organises a peer review involving the participation of all member states. If these evaluations show that the substance has no harmful effects on human or animal health, and no unacceptable influence on the environment, then the substance can be approved. Products containing these active substances are then further evaluated and registered at member state level, according to the principles laid down in the Directive.

Prior to Directive 91/414/EEC, substances and products were evaluated and authorised at national level, with different requirements and procedures in operation in each EU member state. Once the new Directive came into force, in order to bring into line the evaluations and registrations conducted under the old system with those of new approvals, Directive 91/414/EC stipulated that a review must be conducted of all existing active substances in use within the European Union.

There were about 1,000 active substances (and tens of thousands of products containing them) on the market at the time the Directive was adopted. A review period of 12 years was scheduled, starting 2 years after notification of the directive. This period was extended, and officially ended on the 31st of December 2008. Substances for which a definitive decision had not been taken by that date had to be resubmitted and evaluated by 31 December 2010. The period for decision taking has now been extended to end 2012.

The review has led to the removal from the market of many older or outdated pesticides. Of the active substances which were on the market in at least one Member State before 1993, only 26 % (about 250 substances) passed the assessment. The majority (67%) were eliminated either because the dossiers were not submitted, were incomplete, or were withdrawn by industry. About 70 substances actually failed the review and were removed from the market because the evaluation did not show safe use with respect to human health and/or the environment.

The review was used to establish a new list of approved active substances (named Annex I to Directive 91/414/EEC). Individual Member States can now only authorise plant protection products whose active substances are included in this list. When a pesticide is added to Annex 1, it is for a 10 year period from the date of its inclusion. Once its time period under Annex 1 expires, each pesticide must be reviewed again.

Update on the Directive 91/414/EC Review Process (June 2011)

For more details, including the agendas and minutes of the Standing Committee on Phytopharmaceuticals, see:
http://ec.europa.eu/food/committees/regulatory/scfcah/phytopharmaceuticals/index_en.htm

In 2007 some substances under evaluation for listing in Annex I were voluntarily withdrawn from the evaluation in order to allow the possibility for additional data to be submitted. These substances are not included in Annex I, but are listed as ”voluntarily withdrawn”. While the resubmissions and evaluations for these substances are pending, authorizations in Member States were given until 31 December 2010, with use allowed until 31 December 2011. However, as it has become clear that it will not be possible to evaluate and reach decisions on these substances within the original timescale, the deadlines for authorizations of these substances have been extended (under Commission Regulation (EU) No 741/2010 and Commission Decision 2010/455/EU) as follows:
o authorizations for sale and supply are to be withdrawn from 31 December 2011;
o authorizations for storage and use are to be withdrawn from 31 December 2012.

These extensions apply only to the following substances, which were voluntarily withdrawn from the review and resubmitted under the accelerated procedure:
1-decanol, 1-naphthylacetamide, 1-Naphthylacetic acid, 6-benzyladenine, Acetochlor, Acrinathrin, Aluminium sulphate, Asulam, Azadirachtin, Bitertanol, Bromadiolone, Bupirimate, Carbetamide, Carboxin, Chloropicrin, Clethodim, Cycloxydim, Cyproconazole, Dazomet, Diclofop, Diethofencarb, Dithianon, Dodine, Ethoxyquin, Etridiazole, Fenazaquin, Fenbuconazole, Fenbutatin oxide, Fenoxycarb, Fluazifop-P, Flufenoxuron, Fluometuron, Fluquinconazole, Flurochloridone, Flutriafol, Guazatine, Exythiazox, Hymexazol, Indolylbutyric acid, Isoxaben, Lime sulphur, Metaldehyde, Metosulam, Myclobutanil, Oryzalin, Oxyfluorfen, Paclobutrazol, Pencycuron, Prochloraz, Propargite, Propisochlor, Pyridaben, Quinmerac, Sintofen, Tau-fluvalinate, Tebufenozide, Tefluthrin, Terbuthylazine, Zinc phosphide.

New additions to Annex 1 in January-February 2011

Following the EU meetings of 27-28 January 2011, 10 of these active substances that were voluntarily withdrawn have now been included in Annex I (in bold above). These active substances were included under directives published in January and February 2011, with entry into force in June 2011. Of particular interest are those actives included in PIP Technical Itineraries and Guides including: azadirachtin, bupirimate, buprofezin, cyproconazole, fenazaquin, fenbutatin oxide, hexythiazox, lime sulphur, myclobutanil, pencycuron, tau-fluvalinate, and tebufenozide.

Three additional substances which were not voluntary withdrawn, were also included in January 2011 : triflumuron, bispyribac, profoxidim.

Following its review in 2008, the insecticide buprofezin (also recommended in some PIP Itineraries and Guides) was not included in Annex 1. A re-evaluation by the Member State, EFSA and the European Commission was conducted, and subsequently this has now been re-introduced in Annex 1 (under Directive 2001/6/EEC of 20 January 2011, with entry into force from 1st February 2011).

Further substances that have been included recently are: carbetamide, carboxin, cyproconazole, dazomet, metaldehyde, sintofen, fenazaquin, azadirachtin, diclofop, lime sulphur, aluminium sulphate, bromadiolone, paclobutrazol, pencycuron, tebufenozide, dithianon, hexythiazox, flutriafol, flurochloridone and fluometuron oxide.

Flurprimidol , propisochlor, dichlobenil and dicloran have been non-included. There is no opinion as yet on asulam (a decision will be taken through the appeals committee linked to the new comitology procedures)
 

A new legislative framework concerning the sale and supply of pesticide active substances has recently been adopted. The Plant Protection Products Regulation (Regulation EC 1107/2009) came into force on 14 December 2009, and will apply from 14 June 2011. Once it is applied, it will replace Directive 91/414/EEC.

The new Regulation aims, among other things, to ensure maintaining a high level of human, animal and environmental protection as well as to provide clearer rules to make the approval process for plant protection products more transparent. The regulation not only covers active substances but also addresses synergists, safeners, co-formulants & adjuvants.

In contrary to Directive 91/414/EEC, where decisions are based on a comprehensive risk assessment, decisions on the approval of pesticides under the new regulation are based on “hazard-based cut-off criteria”, which consider only the intrinsic chemical properties of a pesticide. This differs markedly from the current approvals process (under 91/414/EEC), which takes into account not only hazard (toxicity), but also risk (whether or not there is any risk from the exposure to the product, depending on how it is used, when, where, how frequently, etc.).

Under the criteria defined in the new Regulation, substances will not be permitted for use (cut off) if they are classified as:

• Category 1 or 2 mutagens;
• Category 1 or 2 carcinogens or reproductive toxins unless exposure is “negligible”;
• Endocrine disruptors which may cause adverse effects unless exposure is “negligible”;
• Persistent Organic Polluters (PoPs);
• Persistent – Bio accumulative – Toxic (PBT);
• Very persistent – very Bio – accumulative (vPvB).

The Council added an important derogation (exception to the rule). This allows for the approval of active substances for a period of five years where it is deemed necessary to “control a serious danger to plant health which cannot be contained by other means”, even if it does not satisfy the requirements on carcinogenic or reproductive toxicity Category 2, or endocrine disruptors. This derogation authorization is renewable, although the Commission has indicated that they would only expect the derogation to be used under exceptional circumstances.

As under the current regulations, all pesticides will be reviewed when they reach their 91/414/EEC Annex 1 expiry dates. Active substances that trigger the cut-off criteria will be banned once their initial 10 year Annex I inclusion comes to an end (although derogation could then apply).

Some substances may be approved, but classified as candidates for substitution. These are substances that may subsequently be eliminated when safer alternatives become available. Substances categorised as “for substitution” can be approved for up to seven years, and this authorisation is renewable. Furthermore, if they are needed for resistance management, they may remain on the market even if there is an available alternative.

The current system will be maintained whereby the evaluation and registration of active substances takes place at EU level, while the evaluation and registration of products containing these active substance takes place at MS level.

The Directive on the Sustainable Use of Pesticides came into force on the 25 November 2009. The key feature of this Directive is that each EU Member State should develop and adopt a National Action Plan to reduce the risks and impacts of pesticide use on human health and the environment, and encourage the development and introduction of integrated pest management and alternative approaches or techniques, in order to reduce dependency on the use of pesticides.

While this Directive is applicable only within the EU, it is important for third countries (including ACP States) in that it is indicative of the general trend within the EU (and EU markets) towards a reduced tolerance of the use of pesticides.

In June 2009, PIP conducted a preliminary assessment of the potential impact of Regulation (EC) No 1107/2009 in ACP countries. The study concluded that though several pesticides currently used on export crops may be withdrawn in Europe, the new Regulation is not likely to have a major impact in ACP countries in the short-term. Substances will remain authorized until they come up for review when their Annex I listing expires (so their MRLs will not change until this expiry date), and even then the possibility of derogations should allow time to develop alternatives. Moreover, when a pesticide is withdrawn in Europe, continued use on ACP crops for export to Europe will still be possible provided that the product is registered locally, and EU MRLs and Import Tolerances are complied with.

PIP concluded that the impact is more likely to be felt over the longer-term, and particularly in the smallholder sector, due to the possible loss (or reduced MRL) of some less expensive, broad spectrum pesticides and consequent increase in production costs.

Certain elements of the new regulation are still to be clarified. For example, the criteria for endocrine disruptors have not yet been finalised, giving rise to considerable uncertainty. It is also as yet unclear if Import Tolerances of substances that are withdrawn (based on public health related cut-off criteria), will be set at the Limit of Quantification (LoQ).

The PIP report concludes that it is vital to begin developing alternative pest management strategies in order to limit the impact when substances are eventually lost. It also highlights the importance of working closely with manufacturers to encourage them to develop new products, and to introduce existing products into ACP countries. Based on the findings of this study, PIP will conduct more detailed evaluations on a crop-by-crop, pest-by-pest basis in order to identify potential problem areas in good time.

On 1 September 2008, Regulation (EC) No 396/2005 came into force. This set harmonised pesticide MRLs for all countries in the EU. The previous MRL regime was too complex as it included harmonised EU as well as divergent national (Member State) rules. This situation led to confusion about which MRL was applicable, and made the life of traders and importers difficult, particularly in cases where food exceeding the defined MRL in one Member State was acceptable in another.

The new harmonised provisions aim to facilitate trade and reduce potential technical barriers. However, it is important to note that there are differences between Codex and EU MRLs, as some EU MRLs are set lower or at the limit of determination. This could be critical because Codex MRLs are the ones used by the WTO in cases of dispute.

All decision-making in this area has to be science-based. To set an MRL, a consumer intake assessment has to be carried out by the rapporteur member state and EFSA. The assessments are based on the properties of the pesticide, on the maximum levels expected on food, and on the different diets of European consumers. These take into consideration the safety of all consumer groups, including, for example, babies, children and vegetarians.

Farmers, traders and importers are responsible for food safety, including compliance with MRLs. Member State authorities are responsible for the control and enforcement of the MRLs. The Commission carries out inspections in Member States to assess and audit their control activities.

A database on the European Commission's website specifies the MRL applicable to each crop and pesticide. This is freely accessible to guarantee transparent and up-to-date information on the EU pesticide residues legislation: http://ec.europa.eu/sanco_pesticides/public/index.cfm

The Annexes to Reg. (EC) No 396/2005 specify the MRLs and the products to which they apply:

• Annex I is the list of products (crops) to which the MRLs apply. Annex I has been established by Commission Regulation (EC) No 178/2006. It contains 315 products, including fruits, vegetables, spices, cereals, and animal products.
• Annex II is the list of EU definitive MRLs and it consolidates the existing EU legislation before 1 September 2008. It specifies MRLs for 245 pesticides.
• Annex III is the list of the so-called EU temporary MRLs. It is the result of the harmonisation process as it lists pesticides for which, before 1 September 2008, MRLs were only set at national level. It specifies MRLs for 471 pesticides.  
• Annex IV is the list of pesticides (52) for which no MRLs are needed because of their low risk.
• Annex V will contain the list of pesticides for which a default limit other than 0,01 mg/kg will apply. This Annex has not been published yet.
• Annex VI will contain the list of conversion factors of MRLs for processed commodities. This Annex has not been published yet.
• Annex VII contains a list of pesticides used as fumigants for which the Member States are allowed to apply special derogations before the products are placed on the market.

If a pesticide is not included in any of the above mentioned Annexes, the MRL is set at the default MRL of 0.01 mg/kg (Art 18(1b) of Reg. (EC) No 396/2005).

If substances are not included in these Annexes (and thus have no MRL), it is still possible to use these on crops being exported to the EU under the following circumstances:

• If the residue levels do not exceed the default MRL (LOQ) of 0.01 mg/kg

• Where there is an Import Tolerance (IT). In cases where there is no EU MRL for a pesticide that is used on a commodity imported into the EU, and where the residue exceeds the default LOQ, an application for an Import Tolerance can be submitted to the EU authorities. The dossier for an IT application must contain information on residues, toxicology, and risks to consumers, as well as an approval for use in the producing country, and a proposed MRL. An IT is a tolerance for a pesticide residue on an imported food or feed for which there is no EU MRL, but that meets EU safety standards.

• Where there is an approved Extrapolation from an existing MRL on a representative crop in the same crop group (e.g. from French beans to snow peas).

A problem facing the fruit and vegetable sector, in particular in ACP countries, is that many crops are classed as “minor crops” because they represent a small market for the plant protection product (PPP) industry. Generating the data needed to establish an MRL is expensive, and for many minor crops in ACP countries it is not an attractive investment for the PPP companies; the market is simply too small to cover the costs. Because of this, in a number of ACP fruit and vegetable crops, there are few or no MRLs for substances needed to control important pests or diseases.

PIP supports the ACP horticultural export sector in the most critical cases where there is no MRL for an affordable and available pesticide to control a serious and economically important pest. In these cases PIP becomes involved in the normally industry-led functions of generating data and establishing MRLs. This is conducted in partnership with plant protection product companies and ACP regulatory authorities. Between 2001 and 2009, PIP secured 39 new MRLs or ITs and 3 extrapolations.