Maximum residue levels in pesticides
European Parliament and Council Regulation (EC) No 396/05/EC
· Scope
This legislation seeks to provide for fixing pan-EU harmonised maximum pesticide residue levels (MRLs) in or on fruits and vegetables. Harmonised MRLs eliminate barriers to trade and increase transparency of these trading parameters to ensure equal competition on the EU internal market and a high level of consumer protection. MRLs are set for individual fruits and vegetables in combination with pesticides. Only fruits and vegetables on the internal market and those imported to this market are applicable; this Regulation is not applicable to produce exported to third countries. To facilitate the flow of safe produce from third countries onto the internal market, import tolerances can be set.
· Definitions
The following definitions are included in this Regulation and can be consulted if required: good agricultural practise (GAP), critical GAP, pesticide residues, maximum residue limit (MRL), CXL, limit of detection (LOD), import tolerance, proficiency test, acute reference dose (ARfD) and acceptable daily intake (ADI).
· Which fruits and vegetables and active substances are covered?
Products of plant origin (fruits and vegetables) listed in Annex I of this Regulation are covered. Where possible, MRLs will be set for groups of similar or related products listed under this Annex. EU Member States can request that this list is revised to take account of new significant trade flows of a certain product.
The setting of permanent MRLs can be considered for any product in combination with an active substance authorised under Directive 91/414/EC. Furthermore, temporary MRLs for substances not yet included in Annex I to Directive 91/414/EC are possible and would be included in Annex III to this Regulation.
Some active substances in combination with certain plant products do not require an MRL. These combinations will be listed in Annex IV to this Regulation.
· Import tolerances
An import tolerance is defined as:
an MRL set for imported products to meet the needs of international trade where:
· the use of the active substance in a plant protection product on a given product is not authorised in the Community for reasons other than public health reasons for the specific product and specific use; or
· a different level is appropriate because the existing Community MRL was set for reasons other than public health reasons for the specific product and specific use
Import tolerances can be requested, providing the information given in the next section is presented, if a trader wishes to import a commodity:
· containing residues of a substance used in the EU but where the commodity is not produced in the EU (e.g. papayas);
· treated with a substance no longer or not yet used in the EU; or
· treated with a substance in use in the EU but where the foreign GAP allows higher residues than the EU’s critical GAP.
More information on import tolerances is given in a paper from the EU to WTO trade partners available here.
· Applying for an MRL to be set
Anyone who has an interest in health or produces, manufactures or trades products listed in Annex I can apply for an MRL, including an import tolerance, to be set. The following information must be provided to an EU Member State on application:
· name and address of applicant;
· an application dossier containing:
Ø a summary of the application;
Ø the main substantive arguments;
Ø an index of documentation; and
Ø a copy of the relevant GAP relevant to the specific use of the active substance.
· a comprehensive overview of concerns regarding the active substance in quest from scientific literature; and
· data listed in Annex II and III to Directive 91/414/EC. Justification must be included for using, or excluding, existing data such as Codex MRLs should be included where appropriate.
Temporary MRLs can be set in the following circumstances:
· exceptional circumstances where pesticides residues arise on crops as a result of environmental contamination, or where a pesticide is authorised as the only option to safeguard against a dangerous situation arisin;
· where concerned products are only a minor part of consumers’ and relevant sub-group’s diet;
· where an essential use is identified following the decision to delete or not include an active substance in Annex I of Directive 91/414/EC; and
· to allow the free trade of a product added to Annex I of this Regulation whilst scientific studies are conducted for a permanent MRL, assuming there are no health concerns.
Once an application to set an MRL has been received, a series of procedures within the MemberState, the European Commission and the European Food Safety Authority must be adhered to as laid down in the Regulation.
Member States may charge fees, based on average costs, associated with setting, modifying or deleting MRLs.
· Fixing new MRLs
Following a successful application, the Commission must publish a Regulation to incorporate the new MRL(s) as either:
· a permanent MRL in Annex II, where the active substance is already listed in Annex I to Directive 91/414/EC; or
· a temporary MRL in Annex III where the active substance is not already included in Annex I to Directive 91/414/EC or Annex II to this Regulation.
· Compliance with MRLs
Traders must ensure that their products comply with the MRLs set in Annex II and III, or if no specific MRL exists (product/active combinations are listed in Annex IV), the default value of 0.01 mg/kg. The default value may vary according to Annex V for some products.
Certain post-harvest treatments with a fumigant can be used according to Member Stateauthorisations (listed in Annex VII), which exceed MRLs laid down in Annexes II and III, assuming that:
· the treated produce is not intended to be marketed to the consumer directly;
· appropriate measures are in place to ensure the consumer does receive the produce before it adheres to the MRL laid down in Annexes II and III to this Regulation; and
· all Member States and the Commission are aware of the situation.
· Existing MRLs
Pre-existing EU harmonised MRLs set under Directive 90/642/EEC shall be directly listed in Annex II as permanent MRLs.
Temporary MRLs for active substances not as yet included in Annex I to Directive 91/414/EC shall be first established and placed in Annex III of this Regulation. MRLs set under Directive 76/895/EEC and unharmonised national MRLs shall be considered with the opinions of MemberStates and EFSA and before these temporary MRLs are fixed.
The Commission shall set temporary MRLs at levels which can be achieved in all Member States on the basis of good agricultural practice. Temporary MRLs shall be evaluated once every ten years
· Mixing of products
Products listed under Annex I which exceed MRLs, must not be mixed with others with a lower pesticide residue, the result being a homogenous mixture which conforms to the appropriate MRL.
· Controls
Controls to enforce this legislation are carried out by Member States at the point of supply to the consumer. Furthermore, a multi-annual community control programme is in place to monitor residues. More details on this scheme can be found in the Fresh Quality Guide here. In addition to Community control programmes, a multi-annual national control programme exists. Much of this information provided by Member States and additional information regarding analysis is used to elaborate an annual report on pesticide residues.
· Emergency measures
Where food is likely to constitute a serious risk to human health, animal health or the environment, the General Food Law (Regulation 178/2002) lays down provisions to be taken by the Commission where Member States’ action needs supporting at the EU level. These measures should be proportional to the risk and will be confirmed, amended, revoked or extended within seven (7) days for fresh fruits and vegetables. Sanctions available to the authorities are as follows:
For EU-produced fruits and vegetables:
· suspension of produce marketing or use of the food;
· laying down special conditions for the food in question; and/or
· any other interim measure.
For imported fruits and vegetables:
· suspension of imports from all or parts of the third country concerned and the third country of transit;
· laying down special conditions for the fruits and vegetables from all or part of the concerned third country; and/or
· any other appropriate measures.
The concerned Member State(s) may take additional short term protective measures where the Commission has not implanted one or more of the appropriate measures above.
· Annexes
Ø Annex I - Commission Regulation 600/2010
List of plant products for which MRLs must be set.
Ø Annex II - Commission Regulations 149/2008 and 839/2008
List of permanent MRLs.
Ø Annex III - Commission Regulations 149/2008 and 839/2008
Lists of temporary MRLs.
Ø Annex IV - Commission Regulations 149/2008 and 839/2008
Combinations of active substances and plant products, for which no MRLs are required.
Ø Annex V
Combinations of active substances and plant products where a limit of detection, other than 0.01 mg/kg, is applicable.
Ø Annex VI
Processing or dilution factors for processed and/or composite products.
Ø , , , ; Annex VII - Commission Regulation 76/2008
Active substance/ pr, oduct combinations fixed by Member States for post-harvest treatments with a fumigant whose MRLs exceed those in Annexes II and III.
Maximum residue levels in pesticides
European Parliament and Council Regulation (EC) No 396/05/EC
· Scope
This legislation seeks to provide for fixing pan-EU harmonised maximum pesticide residue levels (MRLs) in or on fruits and vegetables. Harmonised MRLs eliminate barriers to trade and increase transparency of these trading parameters to ensure equal competition on the EU internal market and a high level of consumer protection. MRLs are set for individual fruits and vegetables in combination with pesticides. Only fruits and vegetables on the internal market and those imported to this market are applicable; this Regulation is not applicable to produce exported to third countries. To facilitate the flow of safe produce from third countries onto the internal market, import tolerances can be set.
· Definitions
The following definitions are included in this Regulation and can be consulted if required: good agricultural practise (GAP), critical GAP, pesticide residues, maximum residue limit (MRL), CXL, limit of detection (LOD), import tolerance, proficiency test, acute reference dose (ARfD) and acceptable daily intake (ADI).
· Which fruits and vegetables and active substances are covered?
Products of plant origin (fruits and vegetables) listed in Annex I of this Regulation are covered. Where possible, MRLs will be set for groups of similar or related products listed under this Annex. EU Member States can request that this list is revised to take account of new significant trade flows of a certain product.
The setting of permanent MRLs can be considered for any product in combination with an active substance authorised under Directive 91/414/EC. Furthermore, temporary MRLs for substances not yet included in Annex I to Directive 91/414/EC are possible and would be included in Annex III to this Regulation.
Some active substances in combination with certain plant products do not require an MRL. These combinations will be listed in Annex IV to this Regulation.
· Import tolerances
An import tolerance is defined as:
an MRL set for imported products to meet the needs of international trade where:
· the use of the active substance in a plant protection product on a given product is not authorised in the Community for reasons other than public health reasons for the specific product and specific use; or
· a different level is appropriate because the existing Community MRL was set for reasons other than public health reasons for the specific product and specific use
Import tolerances can be requested, providing the information given in the next section is presented, if a trader wishes to import a commodity:
· containing residues of a substance used in the EU but where the commodity is not produced in the EU (e.g. papayas);
· treated with a substance no longer or not yet used in the EU; or
· treated with a substance in use in the EU but where the foreign GAP allows higher residues than the EU’s critical GAP.
More information on import tolerances is given in a paper from the EU to WTO trade partners available here.
· Applying for an MRL to be set
Anyone who has an interest in health or produces, manufactures or trades products listed in Annex I can apply for an MRL, including an import tolerance, to be set. The following information must be provided to an EU Member State on application:
· name and address of applicant;
· an application dossier containing:
Ø a summary of the application;
Ø the main substantive arguments;
Ø an index of documentation; and
Ø a copy of the relevant GAP relevant to the specific use of the active substance.
· a comprehensive overview of concerns regarding the active substance in quest from scientific literature; and
· data listed in Annex II and III to Directive 91/414/EC. Justification must be included for using, or excluding, existing data such as Codex MRLs should be included where appropriate.
Temporary MRLs can be set in the following circumstances:
· exceptional circumstances where pesticides residues arise on crops as a result of environmental contamination, or where a pesticide is authorised as the only option to safeguard against a dangerous situation arisin;
· where concerned products are only a minor part of consumers’ and relevant sub-group’s diet;
· where an essential use is identified following the decision to delete or not include an active substance in Annex I of Directive 91/414/EC; and
· to allow the free trade of a product added to Annex I of this Regulation whilst scientific studies are conducted for a permanent MRL, assuming there are no health concerns.
Once an application to set an MRL has been received, a series of procedures within the MemberState, the European Commission and the European Food Safety Authority must be adhered to as laid down in the Regulation.
Member States may charge fees, based on average costs, associated with setting, modifying or deleting MRLs.
· Fixing new MRLs
Following a successful application, the Commission must publish a Regulation to incorporate the new MRL(s) as either:
· a permanent MRL in Annex II, where the active substance is already listed in Annex I to Directive 91/414/EC; or
· a temporary MRL in Annex III where the active substance is not already included in Annex I to Directive 91/414/EC or Annex II to this Regulation.
· Compliance with MRLs
Traders must ensure that their products comply with the MRLs set in Annex II and III, or if no specific MRL exists (product/active combinations are listed in Annex IV), the default value of 0.01 mg/kg. The default value may vary according to Annex V for some products.
Certain post-harvest treatments with a fumigant can be used according to Member Stateauthorisations (listed in Annex VII), which exceed MRLs laid down in Annexes II and III, assuming that:
· the treated produce is not intended to be marketed to the consumer directly;
· appropriate measures are in place to ensure the consumer does receive the produce before it adheres to the MRL laid down in Annexes II and III to this Regulation; and
· all Member States and the Commission are aware of the situation.
· Existing MRLs
Pre-existing EU harmonised MRLs set under Directive 90/642/EEC shall be directly listed in Annex II as permanent MRLs.
Temporary MRLs for active substances not as yet included in Annex I to Directive 91/414/EC shall be first established and placed in Annex III of this Regulation. MRLs set under Directive 76/895/EEC and unharmonised national MRLs shall be considered with the opinions of MemberStates and EFSA and before these temporary MRLs are fixed.
The Commission shall set temporary MRLs at levels which can be achieved in all Member States on the basis of good agricultural practice. Temporary MRLs shall be evaluated once every ten years
· Mixing of products
Products listed under Annex I which exceed MRLs, must not be mixed with others with a lower pesticide residue, the result being a homogenous mixture which conforms to the appropriate MRL.
· Controls
Controls to enforce this legislation are carried out by Member States at the point of supply to the consumer. Furthermore, a multi-annual community control programme is in place to monitor residues. More details on this scheme can be found in the Fresh Quality Guide here. In addition to Community control programmes, a multi-annual national control programme exists. Much of this information provided by Member States and additional information regarding analysis is used to elaborate an annual report on pesticide residues.
· Emergency measures
Where food is likely to constitute a serious risk to human health, animal health or the environment, the General Food Law (Regulation 178/2002) lays down provisions to be taken by the Commission where Member States’ action needs supporting at the EU level. These measures should be proportional to the risk and will be confirmed, amended, revoked or extended within seven (7) days for fresh fruits and vegetables. Sanctions available to the authorities are as follows:
For EU-produced fruits and vegetables:
· suspension of produce marketing or use of the food;
· laying down special conditions for the food in question; and/or
· any other interim measure.
For imported fruits and vegetables:
· suspension of imports from all or parts of the third country concerned and the third country of transit;
· laying down special conditions for the fruits and vegetables from all or part of the concerned third country; and/or
· any other appropriate measures.
The concerned Member State(s) may take additional short term protective measures where the Commission has not implanted one or more of the appropriate measures above.
· Annexes
Ø Annex I - Commission Regulation 600/2010
List of plant products for which MRLs must be set.
Ø Annex II - Commission Regulations 149/2008 and 839/2008
List of permanent MRLs.
Ø Annex III - Commission Regulations 149/2008 and 839/2008
Lists of temporary MRLs.
Ø Annex IV - Commission Regulations 149/2008 and 839/2008
Combinations of active substances and plant products, for which no MRLs are required.
Ø Annex V
Combinations of active substances and plant products where a limit of detection, other than 0.01 mg/kg, is applicable.
Ø Annex VI
Processing or dilution factors for processed and/or composite products.
Ø , , , ; Annex VII - Commission Regulation 76/2008
Active substance/ pr, oduct combinations fixed by Member States for post-harvest treatments with a fumigant whose MRLs exceed those in Annexes II and III.
